Silicone cap BS2303-3
Silicone cap BS2303-3 is a rigid optical bronchoscope (FDA Class II; FDA product code EOQ, Bronchoscope (Flexible Or Rigid)) made by Efer Endoscopy, cleared under FDA 510(k) K854414 on 12 Mar 1986 and listed in FDA GUDID since 7 Nov 2023 (UDI-DI 03700620600198), 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 | Number03700620600198 | Date7 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK854414 | Date12 Mar 1986 | StatusActive |
Official records
- AccessGUDID record 03700620600198
- FDA 510(k) database K854414
Across registries
- FDA 510(k) K854414 decided 12 Mar 1986 Active
- FDA GUDID UDI-DI 03700620600198 listed 7 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K854414
- Listed FDA GUDID 03700620600198
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- Withdrawn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
- BS2303-3
- Primary DI / UDI-DI
- 03700620600198
- 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
Similar devices
Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).
- EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) by Olympus Medical Systems Corporation
- EVIS 200 SYSTEM by Olympus Corp.
- BRONCHOSCOPE, NON-RIGID by Citation Medical Corp.
- Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set by Ambu A/S
- FUJIFILM Ultrasonic Endoscope by FUJIFILM CORPORATION
- Broncoflex Agile; Product Reference: 20030001, Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 by AXESS VISION TECHNOLOGY
- 12067M by Karl Storz SE & CO. KG
- BFlex™ 2 Slim 3.8 Single-Use Bronchoscope by Verathon Medical (Canada) ULC
- Ion Endoluminal System (IF 1000) by Intuitive Surgical, Inc.
- CONMED NB-120 by Conmed Corporation