← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K962555

# OLYMPUS FB SERIES BIOPSY FORCEPS (K962555)

_Olympus America, Inc. · EOQ · Jul 30, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962555

## Device Facts

- **Applicant:** Olympus America, Inc.
- **Product Code:** [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ.md)
- **Decision Date:** Jul 30, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4680
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Intended Use

The Olympus biopsy forceps are intended to be used for the collection of tissue samples under endoscopic observation.

## Device Story

Reusable biopsy forceps; used with bronchoscopes for tissue sampling in respiratory tract; operated by physicians during endoscopic observation; device collects tissue specimens for diagnostic analysis; mechanical operation; manual actuation.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Reusable biopsy forceps; mechanical actuation; designed for use with bronchoscopes; materials and design consistent with predicate devices.

## 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 FB Series of Reusable Biopsy Forceps ([K955065](/device/K955065.md))

## Submission Summary (Full Text)

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JUL 30 1996
K962555

# 510(k) SUMMARY FOR OLYMPUS BIOPSY FORCEPS

Device Name: Olympus FB series biopsy forceps

Common/Usual Name: Biopsy Forceps for use with bronchoscopes (ENT)

Classification Name: Bronchoscopes and Accessories
21 CFR 884.4680, Class II

Predicate Device: Olympus pre-Amendment and 510(k) cleared reusable biopsy forceps.
Olympus FB Series of Reusable Biopsy Forceps (K955065)

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

Summary Preparation Date: June 27, 1996

Statement of Intended Use: The Olympus biopsy forceps are intended to be used for the collection of tissue samples under endoscopic observation.

Device Description: The Olympus biopsy forceps are specifically designed for tissue collection within the respiratory organs. The FB series of biopsy forceps are substantially equivalent in intended use, method of operation, and safety to pre-Amendment and 510(k) cleared reusable biopsy forceps.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962555](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962555)

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