Pti Sternal Closure Wire Suture
FDA 510(k) K910067 · Pioneering Technologies, Inc.
510(k) numberK910067
Submission
- Device name
- Pti Sternal Closure Wire Suture
- Applicant
- Pioneering Technologies, Inc.
Wheat Ridge, CO, US - Received
- January 9, 1991
- Decision date
- May 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4495
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K193209 | Wego-Stainless SteelGAQ · Traditional | Foosin Medical Supplies Inc., Ltd. | 02/19/2020SE |
| K172146 | MeristeelGAQ · Traditional | M/s. Meril Endo Surgery Private Limited. | 02/01/2018SE |
| K170767 | Surgical Stainless Steel Suture, Stainless Steel SutureGAQ · Special | ETHICON, Inc. | 11/01/2017SE |
| K141007 | Demesteel (Stainless Steel) Non-Absorbable SutureGAQ · Traditional | Demetech Corp. | 09/25/2014SE |
| K140127 | Ferrofibre Stainless Steel Suture with CrimpGAQ · Special | Pontis Orthopaedics, LLC | 05/28/2014SE |
| K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5GAQ · Abbreviated | Core Essence Orthopaedics, LLC | 12/24/2008SE |
| K082828 | Suturtek 360 Degree Sternal Closure DeviceGAQ · Special | Suturtek Incorporated | 10/14/2008SE |
| K063603 | Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17GAQ · Abbreviated | Suturtek Incorporated | 02/07/2007SE |
| K042606 | Modification To:Synthes (USA) Titanium WireGAQ · Traditional | Synthes (Usa) | 05/27/2005SE |
More from Synthes (Usa)
| 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 |
| K905068 | Pti Intra-Art (TM) Pick-Up WicksEFQ · Traditional | 12/31/1991SE |
| 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 Sternal Closure Wire Suture cleared by the FDA?
Pti Sternal Closure Wire Suture (K910067) received a 510(k) decision of Substantially Equivalent on May 6, 1991, 117 days after the submission was received.
What is the product code of K910067?
The FDA product code is GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, a Class II (moderate risk) device regulated under 21 CFR 878.4495.