Fibrijet SA-3868
Fibrijet SA-3868 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) K122526 on 16 Nov 2012 and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 00815634020368), 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 | Number00815634020368 | Date25 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122526 | Date16 Nov 2012 | StatusActive |
Official records
- AccessGUDID record 00815634020368
- FDA 510(k) database K122526
Across registries
- FDA 510(k) K122526 decided 16 Nov 2012 Active
- FDA GUDID UDI-DI 00815634020368 listed 25 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K122526
- Listed FDA GUDID 00815634020368
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- Withdrawn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-3868
- Primary DI / UDI-DI
- 00815634020368
- 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.