Kirwan 19-3010
by Kirwan Surgical Products LLC
Kirwan 19-3010 is a Class II device made by Kirwan Surgical Products LLC, cleared under FDA 510(k) K900533 on 9 Apr 1990 and listed in FDA GUDID since 8 Jun 2016 (UDI-DI 00841019100318), 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 | Number00841019100318 | Date8 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK900533 | Date9 Apr 1990 | StatusActive |
Official records
- AccessGUDID record 00841019100318
- FDA 510(k) database K900533
Across registries
- FDA 510(k) K900533 decided 9 Apr 1990 Active
- FDA GUDID UDI-DI 00841019100318 listed 8 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K900533
- Listed FDA GUDID 00841019100318
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- Withdrawn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, single-use
- Model / reference
- 19-3010
- Primary DI / UDI-DI
- 00841019100318
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
- Size
- Length — 5 Inch