Profile: Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family planning, general examination, cervical care, incontinence products, surgical and neonatal products. Some of our products are vacuum assist delivery devices, antepartum fetal monitors, fetal dopplers, colposcopy systems, and colposcopy instruments. Our Mityvac® line of obstetrics products are reusable and reposable. Our MityVac® is based on the reusable MityVac® pump, with a variety of disposable cup configurations. The FetalGard Lite®, is a powerful and flexible system for monitoring fetal heart rate & pressure, critical to healthy outcomes for mother &child. The optional remote care through FetalGard Lite® view software, allows communication with the computer network.

The company was founded in 1990, has revenues of USD 100-500 Million, has ~430 employees and is ISO 9001, CE certified. NYSE:COO (SEC Filings)

FDA Registration Number: 1216677

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• Cryosurgical Accessories, Spray Cone Tip

• Cryosurgical Accessories, Spray Needle

• Cryosurgical System, Closed End Probe Tip

• Cryosurgical Unit (FDA Code: GEH / 878.4350)

• Cryotherapy Unit (FDA Code: HQA / 886.4170) A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.

• Culdoscope and Accessories (FDA Code: HEW / 884.1640) A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.

• Cytology Cervical Spatula (FDA Code: HHT / 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:

• Digital Colposcopy System

• Disposable Examination Gloves

• Disposable Gloves

• Disposable Hot/Cold Pack (FDA Code: IMD / 890.5710) A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

• Disposable Surgical Drape (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Disposable Surgical Instrument (FDA Code: KDC / 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.

• Disposable Suture Needle (FDA Code: GAB / 878.4800)

• Dual Photon Bone Densitometer

• Dual-Incision Filshie Clip Applicator

• Economy Gel Warmer

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Power Generator

• Endocervical aspirator (FDA Code: HFC / 884.1050) An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.

• Endometrial Aspirator (FDA Code: HFF / 884.1060) An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).

• Endometrial Brush (FDA Code: HFE / 884.1100) An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).

• Endometrial Suction Curette and Accessories (FDA Code: HHK / 884.1175) An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

• Endometrial Thermal Ablation Device (FDA Code: MNB)

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Camera without Audio (FDA Code: FWL / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Endoscopic Cleaning Accessories (FDA Code: FEB / 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.

• Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Endoscopic Photographic Accessories (FDA Code: FEM / 876.1500)

• Endoscopic Smoke Removal Tube (FDA Code: FCZ / 876.1500)

• Endoscopic Still Camera (FDA Code: FXM / 878.4160)

• Endoscopic Television Camera without Audio (FDA Code: FWF / 878.4160)

• Endoscopic Video Camera

• Episiotomy Scissors (FDA Code: HDK / 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:

• Expandable Cervical Dilator (FDA Code: HDN / 884.4250) An expandable cervical dilator is an instrument with two handles and two opposing blades used manually to dilate (stretch open) the cervical os.

• Fertility Products, 24-Determination Bi-Layer Kit

• Fertility Products, Acidified Medium

• Fertility Products, Blastocyst Freeze Kit

• Fertility Products, Blastocyst Medium

• Fertility Products, Cleavage Medium

• Fertility Products, Embryo Freeze Kit

• Fertility Products, Embryo Transfer Catheter

• Fertility Products, Endocervical Aspirator

• Fertility Products, Endometrial Suction Curette

• Fertility Products, Fertilization Medium

• Fertility Products, Human Serum Albumin

• Fertility Products, Hyaluronidase

• Fertility Products, Isotonic Solution

• Fertility Products, Malleable Stylet

• Fertility Products, Medium with HEPES