Gauze Sponge 4X4X12 Ply
FDA 510(k) K844726 · Applied Medical
510(k) numberK844726
Submission
- Device name
- Gauze Sponge 4X4X12 Ply
- Applicant
- Applied Medical
Fort Worth, TX, US - Received
- December 4, 1984
- Decision date
- April 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EFQ – Gauze/Sponge, Internal
- Device class
- Unclassified
Other 510(k)s with product code EFQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991757 | Non-Absorbable Gauze for External Use, Sterile and Non SterileEFQ · Traditional | Furlong Industries | 08/12/1999SE |
| K991215 | Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'SEFQ · Traditional | Symtex Healthcare Corp. | 06/11/1999SE |
| K990974 | Vitop DressingEFQ · Traditional | Wonder & Bioenergy Hi-Tech America, Inc. | 06/09/1999SE |
| K990584 | Gauze Sponges: Laparotomy Sponge, X-Ray DetectableEFQ · Traditional | Broadline Medical Industries | 04/23/1999SE |
| K984187 | Crosstex Non-Woven SpongesEFQ · Traditional | Crosstex Intl. | 02/18/1999SE |
| K983016 | Gauze, Sponges, Cat # 11-003EFQ · Traditional | Vitalcare Group, Inc. | 02/12/1999SE |
| K983348 | Dynarex Tracheostomy SpongeEFQ · Traditional | Dynarex Corp. | 12/11/1998SE |
| K983450 | Starryshine Gauze SpongeEFQ · Traditional | T.C. Dental Products, Inc. | 11/12/1998SE |
| K982648 | Joan IIEFQ · Traditional | Celanese Acetate Co. | 09/30/1998SE |
| K980791 | Dumex Pak-Its Woven Ribbon PackingEFQ · Traditional | Dumex Medical Surgical Products, Ltd. | 04/29/1998SE |
More from Dumex Medical Surgical Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K202818 | Voyant Fine Fusion Device (EB230)GEI · Traditional | 12/16/2021SE |
| K191866 | GelPOINT Mini Advanced Access PlatformGCJ · Traditional | 04/29/2020SE |
| K122619 | Epix Irrigation Pump, Epix Suction Irrigation Tubing SetBTA · Traditional | 10/02/2012SE |
| K070865 | Expanding Vascular SheathDYB · Traditional | 10/23/2007SE |
| K003443 | Suction IrrigatorFHF · Traditional | 02/01/2001SE |
| K002915 | Flexible Occlusion SystemDXC · Traditional | 01/08/2001SE |
| K915826 | Bio-Polar ForcepsGEI · Traditional | 06/02/1992SE |
| K911462 | Surgical TrocarDRC · Traditional | 04/22/1991SE |
| K844677 | Applied Gauze Sponge 2X2X12EFQ · Traditional | 04/01/1985SE |
| K844676 | Applied Gauze Sponge 4X4X8EFQ · Traditional | 04/01/1985SE |
Questions and answers
When was Gauze Sponge 4X4X12 Ply cleared by the FDA?
Gauze Sponge 4X4X12 Ply (K844726) received a 510(k) decision of Substantially Equivalent on April 1, 1985, 118 days after the submission was received.
What is the product code of K844726?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.