OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)

K962474 · Olympus America, Inc. · FBO · Dec 20, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962474
• Device Name: OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
• Applicant: Olympus America, Inc.
• Product Code: FBO · Gastroenterology, Urology
• Decision Date: Dec 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue endoscopically.

Device Story

Flexible shaft grasping forceps with proximal control handle; distal tip jaws actuated by handle; used during endoscopic procedures to grasp tissue or retrieve foreign bodies/excised tissue; operated by physician; provides mechanical means for tissue manipulation/retrieval under endoscopic visualization.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Flexible shaft with proximal control handle; mechanical actuation of distal jaws; manual operation; reusable endoscopic accessory.

Indications for Use

Indicated for endoscopic grasping of tissue, retrieval of foreign bodies, and retrieval of excised tissue in patients undergoing endoscopic procedures.

Regulatory Classification

Identification

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.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Olympus Pre-Amendment and 510(k) cleared grasping forceps
• Olympus FG-Series Rat tooth Grasping Forceps (K955051)

Submission Summary (Full Text)

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K962474

# 510(k) SUMMARY FOR OLYMPUS FG GRASPING FORCEPS

DEC 20 1996

| Device Name: | Olympus FG-4/14/20/21/22/26/32/38/40/##-1 Grasping Forceps (Urology) |
| --- | --- |
| Common/Usual Name: | Grasping Forceps |
| Classification Name: | Endoscope and Accessories
21 CFR 876.1500, Class II |
| Predicate Device: | Olympus Pre-Amendment and 510(k) cleared grasping forceps
Olympus FG-Series Rat tooth Grasping Forceps (K955051) |
| Contact Person: | Barry Sands
Olympus America, Inc.
Endoscope Division
2 Corporate Center Drive
Melville, NY 11747-3157
[phone] |

Summary Preparation Date: June 17, 1996

Statement of Intended Use: The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue endoscopically.

Device Description: The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed for grasping tissue and/or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.