← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K962533

# OLYPUS FG SERIES GRASPING FORCEPS (K962533)

_Olympus America, Inc. · EOQ · Aug 9, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962533

## Device Facts

- **Applicant:** Olympus America, Inc.
- **Product Code:** [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ.md)
- **Decision Date:** Aug 9, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4680
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Intended Use

The Olympus FG series of 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 assistance for tissue manipulation and retrieval; benefits patient by enabling minimally invasive removal of foreign objects or biopsy samples.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Flexible shaft, proximal control handle, distal grasping jaws. Reusable design. Materials and construction consistent with predicate Olympus FG series.

## Regulatory 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 FG Reusable Grasping Forceps ([K955066](/device/K955066.md))

## Submission Summary (Full Text)

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K962533

AUG - 9 1996

510(k) SUMMARY FOR OLYMPUS FG GRASPING FORCEPS

Device Name: Olympus FG-4/14/20/21/22/26/32/38/40/##-1 Grasping Forceps (Urology)

Common/Usual Name: Grasping Forceps for bronchoscopy

Classification Name: Bronchoscope and Accessories 21 CFR 874.4680, Class II

Predicate Device: Olympus pre-Amendment and 510(k) cleared grasping forceps Olympus FG Reusable Grasping Forceps (K955066) for GI

Contact Person: Barry Sands
Olympus America, Inc.
Endoscope Division
2 Corporate Center Drive
Melville, NY 11747-3157
(516) 844-5474

Summary Preparation Date: June 26, 1996

Statement of Intended Use: The Olympus FG series of grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body and excised tissue endoscopically.

Device Description: The Olympus FG series of 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.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962533](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962533)

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