AccuDrain® INS8902
AccuDrain® INS8902 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K042825 on 21 Dec 2004 and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780072171), active as of 23 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 | Number10381780072171 | Date22 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042825 | Date21 Dec 2004 | StatusActive |
Official records
- AccessGUDID record 10381780072171
- FDA 510(k) database K042825
Across registries
- FDA 510(k) K042825 decided 21 Dec 2004 Active
- FDA GUDID UDI-DI 10381780072171 listed 22 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K042825
- Listed FDA GUDID 10381780072171
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AccuDrain®
- Generic name
- Laser patient positioning system
- Model / Ref / Catalog
- INS8902
- Primary DI / UDI-DI
- 10381780072171
- 510(k) Number
- FDA product code
- JXG
- GMDN term
- Laser patient positioning system
- Device class
- Class II
- Regulation number
- 882.5550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Laser patient positioning system.