Kirwan 10-2404AUS
by Kirwan Surgical Products LLC 24 variants
Kirwan 10-2404AUS is a Class II device made by Kirwan Surgical Products LLC, cleared under FDA 510(k) K811820 on 28 Jul 1981 and listed in FDA GUDID since 27 Sep 2017 (UDI-DI 00841019115114), 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 | Number00841019115114 | Date27 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK811820 | Date28 Jul 1981 | StatusActive |
Official records
- AccessGUDID record 00841019115114
- FDA 510(k) database K811820
Across registries
- FDA 510(k) K811820 decided 28 Jul 1981 Active
- FDA GUDID UDI-DI 00841019115114 listed 27 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K811820
- Listed FDA GUDID 00841019115114
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kirwan
- Generic name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Model / reference
- 10-2404AUS
- Primary DI / UDI-DI
- 00841019115114
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization