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Blue Silicone CS-B612

by Gyrus Acmi, Inc.

Blue Silicone CS-B612 is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K890328 on 6 Feb 1990 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 00821925038318), active as of 23 Oct 2026. 4 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

6 ongoing

This device is named in the recall

Documents

510(k) K890328

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00821925038318 UDI-DI Date13 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK890328 Date6 Feb 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K890328 decided 6 Feb 1990 Active
  • FDA GUDID UDI-DI 00821925038318 listed 13 Oct 2016 Listed

Recalls

7 recalls · 6 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3300-2026 FDA Class II initiated 24 Aug 2026
    • Ongoing Z-3299-2026 FDA Class II initiated 24 Aug 2026

    There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

    • Ongoing Z-2720-2026 FDA Class II initiated 5 May 2026 on shared 510(k) K890328

    Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

  • 2 recalls, same reason

    • Ongoing Z-2140-2025 FDA Class II initiated 18 Jun 2025
    • Ongoing Z-2139-2025 FDA Class II initiated 18 Jun 2025

    Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

    • Ongoing Z-0568-2024 FDA Class II initiated 2 Oct 2023 on shared 510(k) K890328

    Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

    • Terminated Z-1952-2018 FDA Class II initiated 17 Apr 2018 on shared 510(k) K890328

    There is a potential for the cord to spark and cause a fire.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

9 dated events

  1. Cleared FDA 510(k) K890328
  2. Listed FDA GUDID 00821925038318
  3. Recall initiated FDA recalls Z-1952-2018
  4. Recall initiated FDA recalls Z-0568-2024
  5. Recall initiated FDA recalls Z-2140-2025
  6. Recall initiated FDA recalls Z-2139-2025
  7. Recall initiated FDA recalls Z-2720-2026
  8. Recall initiated FDA recalls Z-3300-2026
  9. Recall initiated FDA recalls Z-3299-2026

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Blue Silicone
Generic name
Endoscope sheath, reusable
Model / reference
CS-B612
Primary DI / UDI-DI
00821925038318
510(k) Number
FDA product code
HIH
GMDN term
Endoscope sheath, reusable
Device class
Class II
Regulation number
884.1690
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscope sheath, reusable

Cleared under the same submission (K890328)

and 8 more cleared under K890328

Similar devices in this category

Other devices filed under Endoscope sheath, reusable.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

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