ST'RIM
by Thiebaud Sas
510(k) K142073
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142073 | Date29 Apr 2015 | 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- Withdrawn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
- MUU
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
ST'RIM is a fat tissue harvest and injection cannula set intended for use in aesthetic body contouring. The modified ST'RIM range and the predicate only differ in size and number of devices available.
The device is a Class 2 General & Plastic Surgery device with product code MUU cleared through the Traditional 510(k) pathway. It is available in multiple sizes including macro, mini, and nano variants. The device is manufactured by Thiebaud Sas and received FDA clearance on 2015-04-29.
Questions
AI-generated answers, 24 Sep 2026
What is the ST'RIM device used for?
ST'RIM is a fat tissue harvest and injection cannula set specifically designed for use in aesthetic body contouring procedures. It comes in multiple sizes including macro, mini, and nano variants to accommodate different clinical needs.
How is the ST'RIM device supplied?
The ST'RIM device is supplied as a complete cannula set for fat harvesting and injection. It is manufactured by Thiebaud Sas and is available in multiple sizes to suit various aesthetic body contouring procedures.
What is the regulatory status of the ST'RIM device?
The ST'RIM device is a Class 2 General & Plastic Surgery device with product code MUU that received FDA clearance through the Traditional 510(k) pathway on April 29, 2015. It is substantially equivalent to its predicate device.
Can the ST'RIM device be reused or is it single-use?
The device data does not specify whether ST'RIM is designed for single-use or reuse. Clinicians should consult the manufacturer's instructions for use to determine the appropriate handling and disposal protocol for this device.