Sponge, Laparotomy Gauze
FDA 510(k) K760113 · Parke-Davis Co.
510(k) numberK760113
Submission
- Device name
- Sponge, Laparotomy Gauze
- Applicant
- Parke-Davis Co.
Mchenry, IL, US - Received
- June 24, 1976
- Decision date
- July 15, 1976
- 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 |
|---|---|---|
| K861725 | Intracath Intravenous Catheter Placement UnitFOZ · Traditional | 12/04/1986SE |
| K862119 | Deseret Flo-Thru Injectate Temperature SensorDYG · Traditional | 08/29/1986SE |
| K855120 | Ati Disposable Biological Test PackFRC · Traditional | 06/18/1986SE |
| K860570 | Angio-Flo Continuous Arterial Cath Flush DeviceKRA · Traditional | 03/31/1986SE |
| K860290 | Viapic Central Line CatheterFOZ · Traditional | 03/18/1986SE |
| K852192 | Disposable Steam Biological Test PackFRC · Traditional | 11/01/1985SE |
| K841967 | Deseret Thermodilution Cardiac OutputDXG · Traditional | 08/19/1985SE |
| K851327 | Deseret Arterial CatheterFOZ · Traditional | 06/14/1985SE |
| K852078 | Spectrum(Tentative)FOZ · Traditional | 06/07/1985SE |
| K844840 | Deseret Introducer SetDYB · Traditional | 05/16/1985SE |
Questions and answers
When was Sponge, Laparotomy Gauze cleared by the FDA?
Sponge, Laparotomy Gauze (K760113) received a 510(k) decision of Substantially Equivalent on July 15, 1976, 21 days after the submission was received.
What is the product code of K760113?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.