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BONETRAP

by Berni Farns Incorporated

510(k) K120189

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 NumberK120189 Date22 Feb 2012ClearedStatusActive

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  • Withdrawn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
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

BONETRAP is an Instrument, Biopsy device used in the specialties of Gastroenterology and Urology. It is a biopsy instrument designed for tissue sampling procedures.

The device was cleared via the FDA 510(k) pathway under K-number K120189 and product code KNW, with a determination of Substantial Equivalence. It is manufactured by Berni Farns Incorporated and classified as a Class II medical device for use in clinical settings requiring biopsy instrumentation.

Questions

AI-generated answers, 22 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 BONETRAP device used for?

    The BONETRAP is a biopsy instrument designed for tissue sampling procedures in the specialties of gastroenterology and urology, as stated in its description and authorization details.

  • How is the BONETRAP device supplied or cleared for use?

    The BONETRAP was cleared via the FDA 510(k) pathway under K-number K120189 with a determination of Substantial Equivalence, and is manufactured by Berni Farns Incorporated as a Class II medical device.

  • What regulatory pathway and classification applies to the BONETRAP?

    The BONETRAP follows the Traditional FDA 510(k) clearance route, was found Substantially Equivalent, and is classified as a Class II device under product code KNW for use in gastroenterology and urology biopsy procedures.