Skin Scrub Tray
510(k) K963721
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963721 | Date27 Nov 1996 | 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- Withdrawn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
- LRO
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Skin Scrub Tray is a medical device used for skin scrubbing. It is classified as a General and Plastic Surgery device with product code LRO.
The Skin Scrub Tray is supplied by Grand Medical Products and has been cleared through the Traditional 510(k) pathway with FDA clearance number K963721. The device is a Class 2 device and has been assigned the decision code SESE, indicating substantial equivalence.
Other devices from Grand Medical Products
Questions
AI-generated answers, 28 Sep 2026
What is the Skin Scrub Tray used for?
The Skin Scrub Tray is used for skin scrubbing, specifically in general and plastic surgery applications.
How is the Skin Scrub Tray supplied?
The Skin Scrub Tray is supplied by Grand Medical Products.
What is the regulatory status of the Skin Scrub Tray?
The Skin Scrub Tray has been cleared through the Traditional 510(k) pathway with FDA clearance number K963721, indicating substantial equivalence.