HighSurg 11 3391FOC
by Nouvag AG
HighSurg 11 3391FOC is a Class II device made by Nouvag AG, cleared under FDA 510(k) K042434 on 3 Nov 2004 and listed in FDA GUDID since 21 Aug 2018 (UDI-DI ENOU3391FOC0), 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 | NumberENOU3391FOC0 | Date21 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042434 | Date3 Nov 2004 | StatusActive |
Official records
- FDA 510(k) database K042434
Across registries
- FDA 510(k) K042434 decided 3 Nov 2004 Active
- FDA GUDID UDI-DI ENOU3391FOC0 listed 21 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K042434
- Listed FDA GUDID ENOU3391FOC0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HighSurg 11
- Generic name
- Line-powered surgical power tool system motor
- Model / reference
- 3391FOC
- Primary DI / UDI-DI
- ENOU3391FOC0
- 510(k) Number
- FDA product code
- HBC, ERL
- GMDN term
- Line-powered surgical power tool system motor
- Device class
- Class II
- Regulation number
- 882.4360, 874.4250
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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