Silicone cap BS2313-3
Silicone cap BS2313-3 is a Class II device made by Efer Endoscopy, cleared under FDA 510(k) K854414 on 12 Mar 1986 and listed in FDA GUDID since 26 Oct 2023 (UDI-DI 03700620600099), active as of 22 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 | Number03700620600099 | Date26 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK854414 | Date12 Mar 1986 | StatusActive |
Official records
- AccessGUDID record 03700620600099
- FDA 510(k) database K854414
Across registries
- FDA 510(k) K854414 decided 12 Mar 1986 Active
- FDA GUDID UDI-DI 03700620600099 listed 26 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K854414
- Listed FDA GUDID 03700620600099
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Silicone cap
- Generic name
- Rigid optical bronchoscope
- Model / reference
- BS2313-3
- Primary DI / UDI-DI
- 03700620600099
- 510(k) Number
- FDA product code
- EOQ
- GMDN term
- Rigid optical bronchoscope
- Device class
- Class II
- Regulation number
- 874.4680
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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