Who is the manufacturer of OLYMPUS FB SERIES BIOPSY FORCEPS?

Olympus America, Inc. filed the 510(k) submission for OLYMPUS FB SERIES BIOPSY FORCEPS (K962555).

What is the FDA product code for OLYMPUS FB SERIES BIOPSY FORCEPS?

EOQ. It is classified under 21 CFR 874.4680 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for OLYMPUS FB SERIES BIOPSY FORCEPS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like OLYMPUS FB SERIES BIOPSY FORCEPS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OLYMPUS FB SERIES BIOPSY FORCEPS

Q: What are the predicate devices for OLYMPUS FB SERIES BIOPSY FORCEPS?

Olympus FB Series of Reusable Biopsy Forceps (K955065).

K962555 · Olympus America, Inc. · EOQ · Jul 30, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K962555
Device Name	OLYMPUS FB SERIES BIOPSY FORCEPS
Applicant	Olympus America, Inc.
Product Code	EOQ · Ear, Nose, Throat
Decision Date	Jul 30, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4680
Device Class	Class 2

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.

Indications for Use

Indicated for tissue collection within respiratory organs during 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 FB Series of Reusable Biopsy Forceps (K955065)

Related Devices

K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS · Ballard Medical Products · Oct 11, 2002
K163377 — Captura Disposable Bronchoscope Biopsy Forceps · Wilson-Cook Medical, Inc. · Feb 21, 2018
K200397 — Single Use Biopsy Forceps FB-456D · Olympus Medical Systems Corp. · Apr 24, 2020
K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR · Telemed Systems, Inc. · Jan 21, 1998
K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps · Boston Scientific Corporation · Sep 26, 2025

Submission Summary (Full Text)

{0} 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.