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Arm Drape SYN-0973

by Advance Medical Designs, Inc.

Arm Drape SYN-0973 is a Class II device made by Advance Medical Designs, Inc., cleared under FDA 510(k) K850959 on 9 Apr 1985 and listed in FDA GUDID since 14 Feb 2024 (UDI-DI 00848340018244), active as of 23 Oct 2026. One FDA recall is 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

None ongoing

1 closed

Documents

510(k) K850959

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 Number00848340018244 UDI-DI Date14 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK850959 Date9 Apr 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K850959 decided 9 Apr 1985 Active
  • FDA GUDID UDI-DI 00848340018244 listed 14 Feb 2024 Listed

Recalls

1 recall · FDA

    • Terminated Z-1036-04 FDA Unclassified (pre-2012) initiated 18 Jun 2004

    The product may come apart when excessive force is applied to the coupler.

Timeline

3 dated events

  1. Cleared FDA 510(k) K850959
  2. Recall initiated FDA recalls Z-1036-04
  3. Listed FDA GUDID 00848340018244

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arm Drape
Generic name
Medical equipment/instrument drape, single-use
Model / reference
SYN-0973
Primary DI / UDI-DI
00848340018244
510(k) Number
FDA product code
JAA
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class II
Regulation number
892.1650
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

From the manufacturer

Manufacturer's product page: Fluid Warmer Drapes

Related devices

Category: Medical equipment/instrument drape, single-use

Cleared under the same submission (K850959)

and 8 more cleared under K850959

Similar devices in this category

Other devices filed under Medical equipment/instrument drape, single-use.

Other devices from Advance Medical Designs, Inc.

See all devices from Advance Medical Designs, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)