Who is the manufacturer of OLYPUS FG SERIES GRASPING FORCEPS?

Olympus America, Inc. filed the 510(k) submission for OLYPUS FG SERIES GRASPING FORCEPS (K962533).

What is the FDA product code for OLYPUS FG SERIES GRASPING 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 OLYPUS FG SERIES GRASPING FORCEPS?

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

Who can help prepare an FDA 510(k) submission like OLYPUS FG SERIES GRASPING 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.

OLYPUS FG SERIES GRASPING FORCEPS

Q: What are the predicate devices for OLYPUS FG SERIES GRASPING FORCEPS?

Olympus FG Reusable Grasping Forceps (K955066).

K962533 · Olympus America, Inc. · EOQ · Aug 9, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K962533
Device Name	OLYPUS FG SERIES GRASPING FORCEPS
Applicant	Olympus America, Inc.
Product Code	EOQ · Ear, Nose, Throat
Decision Date	Aug 9, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4680
Device Class	Class 2
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.

Indications for Use

Indicated for endoscopic grasping of tissue and retrieval of foreign bodies or 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 FG Reusable Grasping Forceps (K955066)

Related Devices

K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) · Olympus America, Inc. · Dec 20, 1996
K962485 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) · Olympus America, Inc. · Aug 20, 1996
K962378 — OLYMPUS FG-45/46-1 GRASPING FORCEPS · Olympus America, Inc. · Aug 2, 1996
K961611 — OLYMPUS BASKET GRASPERS (UROLOGY) · Olympus America, Inc. · Jul 18, 1996
K101298 — ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS · Endochoice, Inc. · Aug 5, 2010

Submission Summary (Full Text)

{0} 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.