OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)

K962485 · Olympus America, Inc. · EOQ · Aug 20, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K962485
• Device Name: OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
• Applicant: Olympus America, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Aug 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

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 grasping forceps; consists of flexible shaft and proximal control handle. Physician operates handle to actuate distal grasping jaws under endoscopic visualization. Used in clinical settings to retrieve foreign objects or tissue samples. Facilitates minimally invasive tissue management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Flexible shaft; proximal control handle; distal grasping jaws. Mechanical actuation. No energy source. Manual operation.

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

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.

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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AUG 20 1996
K962485

# 510(k) SUMMARY FOR OLYMPUS FG GRASPING FORCEPS

| Device Name: | Olympus FG-4/14/20/21/22/26/32/38/40/##-1 Grasping Forceps |
| --- | --- |
| Common/Usual Name: | Grasping Forceps |
| Classification Name: | Bronchoscope and Accessories
21 CFR 874.4680, 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 25, 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. |