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Ensure Sterilization Pouch SCI-SCP

by Scican Ltd

Ensure Sterilization Pouch SCI-SCP is a Class II device made by Scican Ltd, cleared under FDA 510(k) K941327 on 22 Dec 1994 and listed in FDA GUDID since 30 Aug 2018 (UDI-DI 17540196001653), active (FDA 510(k)), not in commercial distribution (GUDID) as of 12 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K941327

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17540196001653 UDI-DI Date30 Aug 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK941327 Date22 Dec 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K941327 decided 22 Dec 1994 Active
  • FDA GUDID UDI-DI 17540196001653 listed 30 Aug 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1791-2022 FDA Class III initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Timeline

3 dated events

  1. Cleared FDA 510(k) K941327
  2. Listed FDA GUDID 17540196001653
  3. Recall initiated FDA recalls Z-1791-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ensure Sterilization Pouch
Generic name
Sterilization packaging, single-use
Model / Ref / Catalog
SCI-SCP
Primary DI / UDI-DI
17540196001653
510(k) Number
FDA product code
KCT
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K941327)

and 8 more cleared under K941327

Similar devices

Other devices filed under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Other devices from Scican Ltd

See all devices from Scican Ltd →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)