Pti Intra-Art (TM) Pick-Up Wicks
FDA 510(k) K905068 · Pioneering Technologies, Inc.
510(k) numberK905068
Submission
- Device name
- Pti Intra-Art (TM) Pick-Up Wicks
- Applicant
- Pioneering Technologies, Inc.
Wheat Ridge, CO, US - Received
- November 9, 1990
- Decision date
- December 31, 1991
- 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 |
|---|---|---|
| K922025 | Anastomart(Tm) Coronary Bypass Graft Markers/ModifDSY · Traditional | 09/22/1992SE |
| K905175 | Pti Annuloplasty Ring(Sterile)KRH · Traditional | 02/14/1992SE |
| K910067 | Pti Sternal Closure Wire SutureGAQ · Traditional | 05/06/1991SE |
| K905067 | Pti Anastomark Flexible Coronary Bypass GraftDSY · Traditional | 03/18/1991SE |
| K901815 | Modified Sterilization of Intra-Art(Tm) CoronaryDRE · Traditional | 07/03/1990SE |
| K901682 | Pti Anastomark(Tm) Coronary Bypass Graft MarkersDSY · Traditional | 07/03/1990SE |
| K901531 | Pti Intra-Artr Reusable Coronary Artery ProbeDNP · Traditional | 06/20/1990SE |
| K901575 | Reusable TENS Paravertebral Pad #641 Back ElectrodGXY · Traditional | 05/02/1990SE |
| K897075 | Pti Intra-Art(Tm) Ansari Saphenous Vein HolderDXC · Traditional | 04/10/1990SE |
| K894684 | Pti Intra-Art Internal Mammary Artery Cannula KitDWF · Traditional | 10/17/1989SE |
Questions and answers
When was Pti Intra-Art (TM) Pick-Up Wicks cleared by the FDA?
Pti Intra-Art (TM) Pick-Up Wicks (K905068) received a 510(k) decision of Substantially Equivalent on December 31, 1991, 417 days after the submission was received.
What is the product code of K905068?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.