Sterile Gauze Product Line
FDA 510(k) K941455 · Cush Medical Products
510(k) numberK941455
Submission
- Device name
- Sterile Gauze Product Line
- Applicant
- Cush Medical Products
Piney Flats, TN, US - Received
- March 25, 1994
- Decision date
- May 20, 1994
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K943424 | Cush Island DressingMGP · Traditional | 10/03/1994SN |
| K940518 | C-Section TrayMLS · Traditional | 08/18/1994SEKD |
| K941349 | Dental TrayEIA · Traditional | 07/26/1994SN |
| K941645 | Biopsy TrayFRG · Traditional | 07/14/1994SEKD |
| K940239 | Eye TrayLRP · Traditional | 06/28/1994SEKD |
| K935684 | IV Start KitLRS · Traditional | 06/10/1994SEKD |
| K941522 | Sterile X-Ray Detectable Gauze SpongesGDY · Traditional | 05/12/1994SE |
| K941344 | Lap Sponge Product LineGDY · Traditional | 05/12/1994SE |
| K935697 | Circumcision TrayHFX · Traditional | 05/02/1994SEKD |
| K936120 | Labor and Delivery TrayMLS · Traditional | 03/30/1994SEKD |
Questions and answers
When was Sterile Gauze Product Line cleared by the FDA?
Sterile Gauze Product Line (K941455) received a 510(k) decision of Unknown on May 20, 1994, 56 days after the submission was received.
What is the product code of K941455?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.