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Halyard 92811

by Avanos Medical, Inc.

Halyard 92811 (69396) is a Class II device made by Avanos Medical, Inc., cleared under FDA 510(k) K892218 on 31 May 1989 and listed in FDA GUDID since 21 Dec 2016 (UDI-DI 10680651928112), active as of 23 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 23 Oct 2026

Documents

510(k) K892218

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 Number10680651928112 UDI-DI Date21 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK892218 Date31 May 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K892218 decided 31 May 1989 Active
  • FDA GUDID UDI-DI 10680651928112 listed 21 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K892218
  2. Listed FDA GUDID 10680651928112

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Halyard
Generic name
Medical device cleaning sponge/set
Model / Ref / Catalog
92811, 69396
Primary DI / UDI-DI
10680651928112
510(k) Number
FDA product code
FGS
GMDN term
Medical device cleaning sponge/set
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FGS (CARRIER, SPONGE, ENDOSCOPIC).

Other devices from Avanos Medical, Inc.

See all devices from Avanos Medical, Inc. →

Properties

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