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Pentax Bs-LC1

by Hoya Corporation

Pentax Bs-LC1 is a Class II device made by Hoya Corporation, cleared under FDA 510(k) K951199 on 10 Apr 1995 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333227747), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K951199

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 Number04961333227747 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951199 Date10 Apr 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951199 decided 10 Apr 1995 Active
  • FDA GUDID UDI-DI 04961333227747 listed 7 Apr 2017 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2065-2016 FDA Class II initiated 6 Apr 2016
    • Terminated Z-2076-2016 FDA Class II initiated 6 Apr 2016

    Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Timeline

4 dated events

  1. Cleared FDA 510(k) K951199
  2. Recall initiated FDA recalls Z-2065-2016
  3. Recall initiated FDA recalls Z-2076-2016
  4. Listed FDA GUDID 04961333227747

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pentax
Generic name
Fibreoptic light cable, reusable
Model / reference
BS-LC1
Primary DI / UDI-DI
04961333227747
FDA product code
EOQ
GMDN term
Fibreoptic light cable, reusable
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fibreoptic light cable

Cleared under the same submission (K951199)

and 5 more cleared under K951199

Similar devices in this category

Other devices filed under Fibreoptic light cable.

Other devices from Hoya Corporation

See all devices from Hoya Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)