Surgical Staple
by United States Surgical, A Division of Tyco Healthc
510(k) K942606
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942606 | Date24 Aug 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- Withdrawn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
- GDW
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4750
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Surgical Staple is a medical device used for implantable stapling. It is classified as a staple, implantable, under the regulation number 878.4750. The device is used in general and plastic surgery.
The Surgical Staple is supplied with various registration numbers, including 3011052945, 3006451981, and 3021604067. It has been authorized with an FDA 510K clearance, with a decision date of 1994-08-24. The device is manufactured by United States Surgical, A Division of Tyco Healthc, and is stored at an address in Norwalk, CT, 06856.
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Questions
AI-generated answers, 23 Sep 2026
What is the Surgical Staple used for?
The Surgical Staple is used for implantable stapling in general and plastic surgery.
Is the Surgical Staple supplied sterile?
The device data does not specify if the Surgical Staple is supplied sterile, but it is intended for implantable use.
What is the regulatory classification of the Surgical Staple?
The Surgical Staple is classified under regulation number 878.4750 as a staple, implantable.