Gemini 2985
Gemini 2985 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K914919 on 9 Jan 1992 and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010113634), 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 | Number03596010113634 | Date30 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK914919 | Date9 Jan 1992 | StatusActive |
Official records
- AccessGUDID record 03596010113634
- FDA 510(k) database K914919
Across registries
- FDA 510(k) K914919 decided 9 Jan 1992 Active
- FDA GUDID UDI-DI 03596010113634 listed 30 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K914919
- Listed FDA GUDID 03596010113634
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gemini
- Generic name
- Electrical-only medical device connection cable, reusable
- Model / Ref / Catalog
- 2985
- Primary DI / UDI-DI
- 03596010113634
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Electrical-only medical device connection cable, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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