X-Ray Guaze Sponges
FDA 510(k) K820106 · Stan-Pak Ent.
510(k) numberK820106
Submission
- Device name
- X-Ray Guaze Sponges
- Applicant
- Stan-Pak Ent.
Mchenry, IL, US - Received
- January 15, 1982
- Decision date
- February 12, 1982
- 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 |
|---|---|---|
| K823058 | Dosometric Release SterilizationEFQ · Traditional | 12/09/1982SE |
| K820100 | Frosted Glass SlidesKEW · Traditional | 03/04/1982SE |
| K820099 | Trach TapeBTO · Traditional | 02/23/1982SE |
| K820155 | Specialist Cast PaddingITG · Traditional | 02/12/1982SE |
| K820140 | Webril Cast PaddingITG · Traditional | 02/12/1982SE |
| K820108 | Topper SpongesNAB · Traditional | 02/12/1982SE |
| K820107 | Guaze Sponges, PlainEFQ · Traditional | 02/12/1982SE |
| K820142 | Tubular StockinetteFQM · Traditional | 02/05/1982SE |
| K820141 | Bias StockinetteFQM · Traditional | 02/05/1982SE |
| K820139 | Sof-Rol Cast PaddingNAB · Traditional | 02/05/1982SE |
Questions and answers
When was X-Ray Guaze Sponges cleared by the FDA?
X-Ray Guaze Sponges (K820106) received a 510(k) decision of Substantially Equivalent on February 12, 1982, 28 days after the submission was received.
What is the product code of K820106?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.