Dynarex Gauze Sponge or Pads
FDA 510(k) K933308 · Dynarex Corp.
510(k) numberK933308
Submission
- Device name
- Dynarex Gauze Sponge or Pads
- Applicant
- Dynarex Corp.
Brewster, NY, US - Received
- July 7, 1993
- Decision date
- December 22, 1993
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K172266 | Dynarex Three-Way StopcockFMG · Traditional | 03/14/2018SE |
| K152970 | Dynarex Xeroform Petrolatum DressingFRO · Traditional | 10/03/2016SE |
| K151575 | Dynarex Eye CupsLXQ · Traditional | 09/01/2015SE |
| K103086 | Dynarex Intermittent Catheters, Male, Female, PediatricEZD · Traditional | 06/07/2011SE |
| K102637 | Dynarex Ultrasound GelMUI · Traditional | 02/16/2011SE |
| K092488 | Dynarex Sterile Lubricating JellyKMJ · Traditional | 12/18/2009SE |
| K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…KNT · Traditional | 01/09/2009SE |
| K081569 | Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with…LZA · Abbreviated | 09/12/2008SE |
| K052743 | Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921CBP · Traditional | 12/22/2005SE |
| K052314 | Dynarex Vaginal Specula 4900, Models 4911-SMALL, 4912-MEDIUM, 4913-LARGEHIB · Traditional | 11/09/2005SE |
Questions and answers
When was Dynarex Gauze Sponge or Pads cleared by the FDA?
Dynarex Gauze Sponge or Pads (K933308) received a 510(k) decision of Substantially Equivalent on December 22, 1993, 168 days after the submission was received.
What is the product code of K933308?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.