Sklar® 91-6115
Sklar® 91-6115 is a Class II device made by Sklar Corporation, cleared under FDA 510(k) K002257 on 19 Oct 2000 and listed in FDA GUDID since 29 Jun 2017 (UDI-DI 50649111005730), 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 | Number50649111005730 | Date29 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK002257 | Date19 Oct 2000 | StatusActive |
Official records
- AccessGUDID record 50649111005730
- FDA 510(k) database K002257
Across registries
- FDA 510(k) K002257 decided 19 Oct 2000 Active
- FDA GUDID UDI-DI 50649111005730 listed 29 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K002257
- Listed FDA GUDID 50649111005730
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sklar®
- Generic name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
- Model / reference
- 91-6115
- Primary DI / UDI-DI
- 50649111005730
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.