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Surgical Instruments Kit

by Clinical Resources, Inc.

510(k) K941466

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)SESK Substantially Equivalent — Kit · Traditional NumberK941466 Date22 Apr 1994ClearedStatusActive

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  • Withdrawn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
FRG
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 27 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 Surgical Instruments Kit is a collection of medical tools designed for use in surgical procedures. It serves as a comprehensive set of instruments intended to facilitate various clinical tasks during operations.

This device is supplied by Clinical Resources, Inc. and has received FDA 510(k) clearance under the reference number K941466. It is categorized under product code FRG.

Other devices from Clinical Resources, Inc.

See all devices from Clinical Resources, Inc. →

Questions

AI-generated answers, 27 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 intended use of the Surgical Instruments Kit?

    This kit is designed as a comprehensive collection of medical tools intended to facilitate various clinical tasks during surgical operations.

  • What is the regulatory status of this device?

    The Surgical Instruments Kit has received FDA 510(k) clearance under the reference number K941466, which indicates it has been reviewed and cleared for use by the FDA.

  • Who is the manufacturer of this surgical kit?

    The device is manufactured and supplied by Clinical Resources, Inc., located in Elgin, Illinois.