Profile: Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retractors, nasal instruments, and tracheal instruments.

The company was founded in 1981 and is ISO 9001:2000, ISO 13485:2003, CE certified.

FDA Registration Number: 8040265
US Agent: Salem Marchants / Carl Heyer Inc.
Phone: +1-(516)-783-7800  E-Mail:

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• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Manual Retractor

• Manual Saw & Accessories (FDA Code: GDR / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Metal Vaginal Speculum (FDA Code: HDF / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Nasal Chisel (FDA Code: KAN / 878.4800)

• Non Rigid Laryngoscope (FDA Code: CAL / 868.5530) A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Non-Illuminated Speculum (FDA Code: FXE / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535) A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

• Non-Self-Retaining Retractor (FDA Code: FGN / 876.4730)

• Non-Surgical Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Ophthalmic Caliper (FDA Code: HOE / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Ophthalmic Curette (FDA Code: HNZ / 886.4350)

• Ophthalmic Forceps (FDA Code: HNR / 886.4350)

• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350)

• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)

• Orthopedic Elevator (FDA Code: HTE / 878.4800)

• Orthopedic Spatula (FDA Code: HXR / 878.4800)

• Rectal Dilator (FDA Code: FFP / 876.5450) A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.

• Rectal Speculums (FDA Code: FFQ / 876.4730)

• Rib Rongeurs (FDA Code: HTX / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Rigid Laryngoscope (FDA Code: CCW / 868.5540) A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Ring Cutters (FDA Code: FNS / 880.6200) A ring cutter is a device intended for medical purposes that is used to cut a ring on a patient's finger so that the ring can be removed. The device incorporates a guard to prevent injury to the patient's finger.

• Saws (FDA Code: HSO / 878.4800)

• Scalpel Blade (FDA Code: GES / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Self-Retaining Retractors (FDA Code: FFO / 876.4730)

• Sensory Evaluation Tuning Fork

• Soft Ear Speculum (FDA Code: EPY / 878.1800)

• Surgical Curette (FDA Code: FZS / 878.4800)

• Surgical Cutter (FDA Code: FZT / 878.4800)

• Surgical Hammer (FDA Code: FZY / 878.4800)

• Surgical Head Hammer (FDA Code: GFB / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Laryngoscope (FDA Code: GCI / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540)

• Surgical Pliers (FDA Code: HTC / 878.4800)

• Surgical Punch (FDA Code: LRY / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Tongue Depressors (FDA Code: FMA / 880.6230)

• Tuning Forks (FDA Code: GWX / 882.1525) A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.

• Uterine Clamp (FDA Code: HGC / 884.4520)

• Uterine Curettes (FDA Code: HCY / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Vaginal Retractors (FDA Code: HDL / 884.4520)