Kirwan 10-4601
by Kirwan Surgical Products LLC
Kirwan 10-4601 is a Class II device made by Kirwan Surgical Products LLC, cleared under FDA 510(k) K831236 on 2 Jun 1983 and listed in FDA GUDID since 5 Apr 2016 (UDI-DI 00841019101810), 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 | Number00841019101810 | Date5 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK831236 | Date2 Jun 1983 | StatusActive |
Official records
- AccessGUDID record 00841019101810
- FDA 510(k) database K831236
Across registries
- FDA 510(k) K831236 decided 2 Jun 1983 Active
- FDA GUDID UDI-DI 00841019101810 listed 5 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K831236
- Listed FDA GUDID 00841019101810
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kirwan
- Generic name
- Electrical-only medical device connection cable, single-use
- Model / reference
- 10-4601
- Primary DI / UDI-DI
- 00841019101810
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrical-only medical device connection cable, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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