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Coecide™ Xl 551128

by Gc America Inc.

Coecide™ Xl 551128 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K931052 on 6 Dec 1994 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D6585511281), 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

1 ongoing

This device is named in the recall

Documents

510(k) K931052

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 NumberD6585511281 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK931052 Date6 Dec 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K931052 decided 6 Dec 1994 Active
  • FDA GUDID UDI-DI D6585511281 listed 1 Aug 2016 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1614-2022 FDA Class II 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.

    • Terminated Z-1721-2019 FDA Class II initiated 13 Jul 2018

    Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.

Timeline

4 dated events

  1. Cleared FDA 510(k) K931052
  2. Listed FDA GUDID D6585511281
  3. Recall initiated FDA recalls Z-1721-2019
  4. Recall initiated FDA recalls Z-1614-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Coecide™ Xl
Generic name
Medical device-decontamination agent
Model / Ref / Catalog
551128
Primary DI / UDI-DI
D6585511281
510(k) Number
FDA product code
MED
GMDN term
Medical device-decontamination agent
Device class
Class II
Regulation number
880.6885
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical device-decontamination agent

Similar devices

Other devices filed under FDA product code MED (Sterilant, medical devices).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

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