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Halyard 39715

by O&M Halyard Inc.

Halyard 39715 is a Class II device made by O&M Halyard Inc., cleared under FDA 510(k) K080795 on 3 Sep 2008 and listed in FDA GUDID since 15 Apr 2016 (UDI-DI 10680651397154), 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) K080795

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 Number10680651397154 UDI-DI Date15 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK080795 Date3 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080795 decided 3 Sep 2008 Active
  • FDA GUDID UDI-DI 10680651397154 listed 15 Apr 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080795
  2. Listed FDA GUDID 10680651397154

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  • Withdrawn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
Surgical gown, single-use
Model / reference
39715
Primary DI / UDI-DI
10680651397154
510(k) Number
FDA product code
FYA
GMDN term
Surgical gown, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical gown, single-use

Cleared under the same submission (K080795)

and 8 more cleared under K080795

Similar devices

Other devices filed under FDA product code FYA (GOWN, SURGICAL).

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)