← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K962378

# OLYMPUS FG-45/46-1 GRASPING FORCEPS (K962378)

_Olympus America, Inc. · EOQ · Aug 2, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962378

## Device Facts

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

## 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.

## 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-2 Reusable Grasping Forceps

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{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.

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962378](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K962378)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com