Who is the manufacturer of OLYMPUS FG-45/46-1 GRASPING FORCEPS?

Olympus America, Inc. filed the 510(k) submission for OLYMPUS FG-45/46-1 GRASPING FORCEPS (K962378).

What is the FDA product code for OLYMPUS FG-45/46-1 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 OLYMPUS FG-45/46-1 GRASPING FORCEPS?

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

Who can help prepare an FDA 510(k) submission like OLYMPUS FG-45/46-1 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.

OLYMPUS FG-45/46-1 GRASPING FORCEPS

Q: What are the predicate devices for OLYMPUS FG-45/46-1 GRASPING FORCEPS?

Olympus FG-2 Reusable Grasping Forceps.

K962378 · Olympus America, Inc. · EOQ · Aug 2, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K962378
Device Name	OLYMPUS FG-45/46-1 GRASPING FORCEPS
Applicant	Olympus America, Inc.
Product Code	EOQ · Ear, Nose, Throat
Decision Date	Aug 2, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4680
Device Class	Class 2

Intended Use

The Olympus FG-45/46-1 Grasping Forceps is intended to be used to retrieve foreign bodies and excised tissue specimens endoscopically.

Device Story

Flexible grasping forceps for endoscopic use; consists of proximal control handle and flexible shaft with distal grasping prong mechanism. Operated by physician during endoscopic procedures to retrieve foreign bodies or tissue specimens under visualization. Mechanical actuation of handle closes distal prongs to secure target material. Facilitates specimen collection and foreign body removal, aiding diagnostic or therapeutic endoscopic interventions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical grasping forceps; flexible shaft; proximal control handle; distal prong mechanism. Manual operation. Reusable design.

Indications for Use

Indicated for endoscopic retrieval of foreign bodies and excised tissue specimens 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-2 Reusable Grasping Forceps

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
K962533 — OLYPUS FG SERIES GRASPING FORCEPS · Olympus America, Inc. · Aug 9, 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} K962378 AUG - 2 1996 510(k) SUMMARY FOR OLYMPUS FG-45/46-1 GRASPING FORCEPS Device Name: Olympus FG-45/46-1 Grasping Forceps Common/Usual Name: Grasping Forceps Classification Name: Bronchoscope and Accessories 21 CFR 876.4680, Class II Predicate Device: Olympus FG-2 Reusable Grasping Forceps Contact Person: Barry Sands Olympus America, Inc. Endoscope Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5747 Summary Preparation Date: June 13, 1996 Statement of Intended Use: The Olympus FG-45/46-1 Grasping Forceps is intended to be used to retrieve foreign bodies and excised tissue specimens endoscopically. Device Description: The Olympus FG-45/46-1 Grasping Forceps is specifically designed for foreign body and tissue specimen collection under endoscopic visualization. The FG-45/46-1 consists of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping prong mechanism.