Kirwan 10-9070
by Kirwan Surgical Products LLC
Kirwan 10-9070 is an electrosurgical system generator (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Kirwan Surgical Products LLC, cleared under FDA 510(k) K052203 on 20 Oct 2005 and listed in FDA GUDID since 10 Apr 2016 (UDI-DI 00841019102480), 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 | Number00841019102480 | Date10 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052203 | Date20 Oct 2005 | StatusActive |
Official records
- AccessGUDID record 00841019102480
- FDA 510(k) database K052203
Across registries
- FDA 510(k) K052203 decided 20 Oct 2005 Active
- FDA GUDID UDI-DI 00841019102480 listed 10 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K052203
- Listed FDA GUDID 00841019102480
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kirwan
- Generic name
- Electrosurgical system generator
- Model / reference
- 10-9070
- Primary DI / UDI-DI
- 00841019102480
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system generator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electrosurgical system generator.
- VOYANT® Electrosurgical Generator EA020 by APPLIED MEDICAL RESOURCES CORP.
- ERBE 10140-500 by Erbe Elektromedizin GmbH
- AEX™ 40-405-1 by Medtronic Navigation Inc.
- J-Plasma APYX-JS3 by Apyx Medical Corporation
- Vaporflex® JVC35020 by Joimax GmbH
- ZIP Pen 252510 by Megadyne Medical Products, Inc.
- Olympus WA90150W by Olympus Winter & Ibe GmbH
- Renuvion APYX-RS3 by Apyx Medical Corporation
- Endovapor® JEVD0201 by Joimax GmbH
- Finesse+, 230VAC FIN-220 by Utah Medical Products, Inc.