Skip to content

Noetix Biopsy Needle

by Noetix, Inc.

510(k) K893992

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 NumberK893992 Date8 Sep 1989ClearedStatusActive

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  • Withdrawn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, 21 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 Noetix Biopsy Needle is a medical device designed for the collection of tissue samples. It is categorized under product code KNW and is intended for use in gastroenterology and urology procedures.

This device is subject to FDA 510(k) clearance under K893992. It is classified as an FDA class 2 device under regulation number 876.1075.

Other devices from Noetix, Inc.

Questions

AI-generated answers, 21 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 primary clinical application for the Noetix Biopsy Needle?

    The Noetix Biopsy Needle is specifically designed for the collection of tissue samples. It is intended for use by clinicians performing procedures within the fields of gastroenterology and urology.

  • What is the regulatory status of this biopsy needle?

    The Noetix Biopsy Needle is an FDA class 2 device under regulation number 876.1075. It has received FDA 510(k) clearance under submission number K893992, which indicates that the device has been found substantially equivalent to legally marketed predicate devices.

  • How is this device categorized for regulatory purposes?

    The device is categorized under product code KNW, which relates to gastroenterology and urology biopsy instruments. This classification is managed by the Gastroenterology and Urology advisory committee.