Adi Sterile Gauze Sponges

FDA 510(k) K953501 · Asia Dynamics, Inc.

Substantially Equivalent

510(k) numberK953501

Submission

Device name
Adi Sterile Gauze Sponges
Applicant
Asia Dynamics, Inc.
Niles, IL, US
Received
July 26, 1995
Decision date
August 28, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EFQ – Gauze/Sponge, Internal
Device class
Unclassified

Other 510(k)s with product code EFQ

510(k)DeviceApplicantDecision
K991757Non-Absorbable Gauze for External Use, Sterile and Non SterileEFQ · Traditional Furlong Industries08/12/1999SE
K991215Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'SEFQ · Traditional Symtex Healthcare Corp.06/11/1999SE
K990974Vitop DressingEFQ · Traditional Wonder & Bioenergy Hi-Tech America, Inc.06/09/1999SE
K990584Gauze Sponges: Laparotomy Sponge, X-Ray DetectableEFQ · Traditional Broadline Medical Industries04/23/1999SE
K984187Crosstex Non-Woven SpongesEFQ · Traditional Crosstex Intl.02/18/1999SE
K983016Gauze, Sponges, Cat # 11-003EFQ · Traditional Vitalcare Group, Inc.02/12/1999SE
K983348Dynarex Tracheostomy SpongeEFQ · Traditional Dynarex Corp.12/11/1998SE
K983450Starryshine Gauze SpongeEFQ · Traditional T.C. Dental Products, Inc.11/12/1998SE
K982648Joan IIEFQ · Traditional Celanese Acetate Co.09/30/1998SE
K980791Dumex Pak-Its Woven Ribbon PackingEFQ · Traditional Dumex Medical Surgical Products, Ltd.04/29/1998SE

More from Dumex Medical Surgical Products, Ltd.

510(k)DeviceDecision
K953500Hemo-BarrierKMF · Traditional 01/24/1996SE
K952924Adi Catheter with ValveGBM · Traditional 08/18/1995SE
K891160Mic Non-Sterile Latex GlovesLYY · Traditional 10/13/1989SE

Questions and answers

When was Adi Sterile Gauze Sponges cleared by the FDA?

Adi Sterile Gauze Sponges (K953501) received a 510(k) decision of Substantially Equivalent on August 28, 1995, 33 days after the submission was received.

What is the product code of K953501?

The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.