DeRoyal 88-000102
DeRoyal 88-000102 is a Class II device made by Deroyal Industries, Inc., cleared under FDA 510(k) K130027 on 22 Aug 2013 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00749756053297), 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 | Number00749756053297 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130027 | Date22 Aug 2013 | StatusActive |
Official records
- AccessGUDID record 00749756053297
- FDA 510(k) database K130027
Across registries
- FDA 510(k) K130027 decided 22 Aug 2013 Active
- FDA GUDID UDI-DI 00749756053297 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K130027
- Listed FDA GUDID 00749756053297
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DeRoyal
- Generic name
- Electrosurgical system
- Model / reference
- 88-000102
- Primary DI / UDI-DI
- 00749756053297
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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