Implantable Clip
by United States Surgical, A Division of Tyco Healthc 3 variants
510(k) K970793
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970793 | Date30 Jul 1997 | 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- Withdrawn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
- FZP
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Implantable Clip is a medical device classified as an implantable clip. It is designed for use in general and plastic surgery procedures.
This device is manufactured by United States Surgical, a division of Tyco Healthcare, and has received FDA 510(k) clearance. It is regulated under the product code FZP and regulation number 878.4300.
Other devices from United States Surgical, A Division of Tyco Healthc
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Questions
AI-generated answers, 21 Sep 2026
What is the intended use of the Implantable Clip?
The Implantable Clip is designed for use by clinicians during general and plastic surgery procedures.
What is the regulatory status of this device?
This device has received FDA 510(k) clearance, which indicates that it has been found to be substantially equivalent to other legally marketed devices.
Under what classification is this device regulated?
The Implantable Clip is regulated under product code FZP and regulation number 878.4300, which pertains to implantable clips used in surgery.