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Silicone cap BS2301-3

by Efer Endoscopy

Silicone cap BS2301-3 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 7 Nov 2023 (UDI-DI 03700620600211), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K854414

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700620600211 UDI-DI Date7 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK854414 Date12 Mar 1986DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K854414 decided 12 Mar 1986 Active
  • FDA GUDID UDI-DI 03700620600211 listed 7 Nov 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K854414
  2. Listed FDA GUDID 03700620600211

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Silicone cap
Generic name
Rigid optical bronchoscope
Model / reference
BS2301-3
Primary DI / UDI-DI
03700620600211
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

Related devices

Category: Rigid optical bronchoscope

Cleared under the same submission (K854414)

and 8 more cleared under K854414

Similar devices

Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).

Other devices from Efer Endoscopy

See all devices from Efer Endoscopy →

Properties

  • Sterilise before use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)