Fluff Gauze Sponge
FDA 510(k) K945020 · Clinical Resources, Inc.
510(k) numberK945020
Submission
- Device name
- Fluff Gauze Sponge
- Applicant
- Clinical Resources, Inc.
Elgin, IL, US - Received
- October 12, 1994
- Decision date
- December 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K941470 | Tracheostomy Care KitBTO · Traditional | 02/14/1995SESK |
| K944882 | Irrigation TrayEYN · Traditional | 01/12/1995SE |
| K944881 | Skin Scrub TrayFRG · Traditional | 12/27/1994SEKD |
| K945021 | Fluff Gauze SpongeEFQ · Traditional | 12/23/1994SE |
| K945019 | Fluff Gauxze RollEFQ · Traditional | 12/23/1994SE |
| K944879 | Gauze SpongesGDY · Traditional | 12/23/1994SE |
| K944880 | Bodily Fluid Disposal KitFXX · Traditional | 12/15/1994SE |
| K941471 | Central Line Dressing Change TrayFRG · Traditional | 05/12/1994SE |
| K941469 | IV Start KitLRS · Traditional | 05/12/1994SE |
| K941468 | Debridement Tray, Incision and Drainage TrayFRG · Traditional | 05/12/1994SE |
Questions and answers
When was Fluff Gauze Sponge cleared by the FDA?
Fluff Gauze Sponge (K945020) received a 510(k) decision of Substantially Equivalent on December 23, 1994, 72 days after the submission was received.
What is the product code of K945020?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.