Fibrijet SA-3657
Fibrijet SA-3657 is an open-surgery adhesive/sealant applicator (FDA Class II; FDA product code GCJ, Laparoscope, General & Plastic Surgery) made by Micromedics, Inc., cleared under FDA 510(k) K042834 on 11 Feb 2005 and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 00815634020177), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00815634020177 | Date25 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK042834 | Date11 Feb 2005 | StatusActive |
Official records
- AccessGUDID record 00815634020177
- FDA 510(k) database K042834
Across registries
- FDA 510(k) K042834 decided 11 Feb 2005 Active
- FDA GUDID UDI-DI 00815634020177 listed 25 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K042834
- Listed FDA GUDID 00815634020177
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fibrijet
- Generic name
- Open-surgery adhesive/sealant applicator, dual-channel
- Model / reference
- SA-3657
- Primary DI / UDI-DI
- 00815634020177
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Open-surgery adhesive/sealant applicator, dual-channel
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Open-surgery adhesive/sealant applicator, dual-channel.