Optim Incorporated

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Contact: Anna Melander - Contract Sales Manager
Web: http://www.optimnet.com
E-Mail:
Address: 64 Technology Park Road, Sturbridge, Massachusetts 01566, USA
Phone: +1-(508)-347-5100, 800-225-7486 | Fax: +1-(508)-347-2380 | Map/Directions >>

Profile: Optim Incorporated manufactures articulating fiber optic endoscopes. We produce medical endoscope models for our private-label (OEM) customers, branded products for direct sale, and endoscope subassemblies for other medical device manufacturers & endoscope repair companies. Our ENT 3.6F flexible nasopharyngoscope is a device for visualization & diagnosis by otolaryngologists, head & neck surgeons, plastic surgeons, speech pathologists and audiologists. It provides the physician with imaging for minimally-invasive diagnostic and surgical applications. It is available with an integral light guide cable (FL30) or with a universal post (FP30) for attachment and removal of light guide cables & portable light sources.

The company was founded in 1971, has revenues of USD 5-10 Million, has ~50 employees and is ISO 9001: 2000, ISO 13485:2003 certified.

FDA Registration Number: 1218141

19 Products/Services (Click for related suppliers)

• Cystourethroscope (FDA Code: FBO / 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.

• Endoscope Accessories (FDA Code: KOG)

• Fiberoptic Endoscope (FDA Code: GDB / 876.1500)

• Fiberoptic Light Source & Carrier (FDA Code: EQH / 874.4350)

An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.

• Flexible Endoscopes (FDA Code: GCQ / 876.1500)

• Flexible/Rigid Bronchoscope (FDA Code: EOQ / 874.4680)

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

• Flexible/Rigid Nasopharyngoscope (FDA Code: EOB / 874.4760)

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

• Flexible/Rigid Ureteroscope and Accessories (FDA Code: FGB / 876.1500)

• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700)

A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

• Hysteroscope and Accessories (FDA Code: HIH / 884.1690)

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

• Laryngoscope/Nasopharyngoscope (FDA Code: EQN / 874.4760)

• LED Light Source (FDA Code: NTN / 876.1500)

• LED Light Source for Borescope

• LED Nasopharyngoscopes

• Light Sources Led Light Source

• Neurological Endoscope (FDA Code: GWG / 882.1480)

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

• 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.

• 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.

• Sinuscopes