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Single Use Biopsy Forceps FB-456D

by Olympus Medical Systems Corp.

510(k) K200397

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200397 Date24 Apr 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EOQ
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Single Use Biopsy Forceps FB-456D is a medical device designed for obtaining tissue samples during diagnostic procedures. It is intended for use in ear, nose, and throat applications, providing a means to collect specimens for pathological examination.

This device is supplied as single-use and is not intended for reuse. It is manufactured by Olympus Medical Systems Corp. and has received FDA 510(k) clearance with the product code EOQ. The device is stored according to the manufacturer's instructions and should be handled in accordance with standard medical procedures.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Single Use Biopsy Forceps FB-456D designed for?

    The Single Use Biopsy Forceps FB-456D is specifically designed for obtaining tissue samples during diagnostic procedures in ear, nose, and throat applications. It provides a means to collect specimens for pathological examination.

  • Is the FB-456D reusable or single-use?

    The FB-456D is supplied as single-use and is not intended for reuse. This design ensures patient safety and prevents cross-contamination between procedures.

  • What regulatory approvals does the FB-456D have?

    The FB-456D has received FDA 510(k) clearance with product code EOQ, classified under the Ear, Nose, Throat advisory committee. It was determined to be substantially equivalent to predicate devices.

  • How should the FB-456D be stored?

    The device should be stored according to the manufacturer's instructions. Proper storage ensures the device maintains its integrity and functionality until use.