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Ingress Technologies Auto BX Biopsy Needle

by The Witmoore Group, Inc.

510(k) K896932

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 NumberK896932 Date22 Jun 1990ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 6 Oct 2026

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

This device is a biopsy needle, as defined by its classification name and device type. It is a medical device intended for obtaining tissue samples in gastroenterology and urology procedures.

It is supplied as a sterile, single-use device and has received FDA 510(k) clearance (K896932) under regulation 876.1075. The device is classified as Class II, with product code FCG, and was cleared via the traditional pathway on June 22, 1990.

Other devices from The Witmoore Group, Inc.

Questions

AI-generated answers, 6 Oct 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 INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE used for?

    This device is intended for obtaining tissue samples during gastroenterology and urology procedures, as defined by its classification name and device type as a biopsy needle.

  • How is the INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE supplied and is it reusable?

    The device is supplied as a sterile, single-use product, meaning it is designed for one-time use only and should not be reprocessed or reused after initial application.

  • What regulatory pathway and clearance does the INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE have?

    It received FDA 510(k) clearance (K896932) via the traditional pathway on June 22, 1990, under regulation 876.1075, and is classified as a Class II medical device with product code FCG.