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Grice Soft Tissue Biopsy Kit

by Ideal Medical, Inc.

510(k) K922161

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 NumberK922161 Date13 Oct 1992ClearedStatusActive

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  • Withdrawn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, 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.

The Grice Soft Tissue Biopsy Kit is a biopsy instrument designed for the collection of soft tissue samples. It is classified as a medical device for use within the fields of gastroenterology and urology.

This device is identified by FDA 510(k) number K922161 and is categorized as a class 2 medical device. It is manufactured by Ideal Medical, Inc. and has received FDA 510(k) clearance.

Other devices from Ideal Medical, Inc.

See all devices from Ideal Medical, 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 intended use of the Grice Soft Tissue Biopsy Kit?

    The Grice Soft Tissue Biopsy Kit is a medical instrument specifically engineered for the collection of soft tissue samples. It is intended for clinical use within the fields of gastroenterology and urology.

  • What is the regulatory status of this biopsy kit?

    This device is manufactured by Ideal Medical, Inc. and is identified by the FDA 510(k) number K922161. It is classified as a class 2 medical device and has received FDA 510(k) clearance.

  • Which medical specialties is this biopsy kit designed for?

    The device is categorized under the product code KNW and falls under the oversight of the Gastroenterology and Urology advisory committee, reflecting its specific application in these medical specialties.