Surgical Instruments Kit
510(k) K941466
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK941466 | Date22 Apr 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Questions
AI-generated answers, 27 Sep 2026
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.