Gauze Sponge, Non X-Ray Detectable
FDA 510(k) K963724 · Grand Medical Products
510(k) numberK963724
Submission
- Device name
- Gauze Sponge, Non X-Ray Detectable
- Applicant
- Grand Medical Products
Schaumburg, IL, US - Received
- September 16, 1996
- Decision date
- November 29, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
|---|---|---|
| K963723 | Laceration TrayLRP · Traditional | 11/27/1996SE |
| K963722 | IV Start KitLRS · Traditional | 11/27/1996SE |
| K963721 | Skin Scrub TrayLRO · Traditional | 11/27/1996SE |
| K963720 | Tracheostomy KitLRQ · Traditional | 11/27/1996SE |
| K963719 | Central Line Dressing Change Tray, Tpn/Cvp Dressing Change TrayMCY · Traditional | 11/27/1996SE |
| K963715 | Debridement Tray, Incision and Drainage TrayLRO · Traditional | 11/27/1996SE |
| K963714 | Grand Medical Suture Removal KitMCZ · Traditional | 11/27/1996SE |
Questions and answers
When was Gauze Sponge, Non X-Ray Detectable cleared by the FDA?
Gauze Sponge, Non X-Ray Detectable (K963724) received a 510(k) decision of Substantially Equivalent for Some Indications on November 29, 1996, 74 days after the submission was received.
What is the product code of K963724?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.