S1 Cavity Packing
FDA 510(k) K861445 · Surgical Specialties, Inc.
510(k) numberK861445
Submission
- Device name
- S1 Cavity Packing
- Applicant
- Surgical Specialties, Inc.
Readding, PA, US - Received
- April 17, 1986
- Decision date
- May 6, 1986
- 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 |
|---|---|---|
| K160744 | LOOK PTFE SutureNBY · Traditional | 07/13/2016SE |
| K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignGAM · Special | 07/30/2014SE |
| K141625 | Polysyn Surgical SutureGAM · Special | 07/18/2014SE |
| K141558 | Quill Monoderm Knotless Tissue-Closure DeviceGAM · Special | 07/11/2014SE |
| K140227 | Monoderm Surgical SutureGAM · Special | 02/28/2014SE |
| K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)NEW · Special | 04/23/2008SE |
| K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneNEW · Special | 03/21/2008SE |
| K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialNEW · Traditional | 08/06/2007SE |
| K072028 | Quill Self-Retaining System (SRS) Comprised of MonodermGAM · Traditional | 08/03/2007SE |
| K063680 | Sharpoint Pdo (Polydioxanone) SuturesNEW · Traditional | 05/09/2007SE |
Questions and answers
When was S1 Cavity Packing cleared by the FDA?
S1 Cavity Packing (K861445) received a 510(k) decision of Substantially Equivalent on May 6, 1986, 19 days after the submission was received.
What is the product code of K861445?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.