Gauze Sponge
FDA 510(k) K884826 · Medical Action Industries, Inc.
510(k) numberK884826
Submission
- Device name
- Gauze Sponge
- Applicant
- Medical Action Industries, Inc.
Farmingdale, NY, US - Received
- November 18, 1988
- Decision date
- December 22, 1988
- 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 |
|---|---|---|
| K042526 | Drape, Surgical, X-Ray Element, Models Non Sterile 6120-00, Sterile 704-B, Non Sterile…KKX · Traditional | 04/25/2005SE |
| K042527 | Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional | 11/08/2004SE |
| K022948 | Vaginal Speculum, Model 5555S, 5555M, or 5555LHIB · Traditional | 11/04/2002SE |
| K946019 | Surgicla Instrument KitFRG · Traditional | 03/20/1995SE |
| K923846 | Burn DressingNAB · Traditional | 09/11/1992SE |
| K810685 | Suture Removal KitGEN · Traditional | 03/26/1981SE |
| K810184 | Laparotomy SpongeGDY · Traditional | 02/04/1981SE |
Questions and answers
When was Gauze Sponge cleared by the FDA?
Gauze Sponge (K884826) received a 510(k) decision of Substantially Equivalent on December 22, 1988, 34 days after the submission was received.
What is the product code of K884826?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.