Stainless Steel Suture
FDA 510(k) K931915 · Surgimetrics International, Ltd.
510(k) numberK931915
Submission
- Device name
- Stainless Steel Suture
- Applicant
- Surgimetrics International, Ltd.
Norcross, GA, US - Received
- April 16, 1993
- Decision date
- March 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203855 | CoNextions TR Tendon Repair SystemGAQ · Traditional | Conextions Medical | 04/22/2022SE |
| 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 |
|---|---|---|
| K931914 | Suture Non-Absorbable Synthetic PolylmideGAR · Traditional | 10/05/1994SE |
| K931919 | Catgut Suture ChromicGAL · Traditional | 03/03/1994SE |
| K931918 | Catgut Suture PlainGAL · Traditional | 03/03/1994SE |
| K931917 | Suture Non-Absorbable Synthetic PolypropyleneGAW · Traditional | 03/03/1994SE |
| K931916 | Suture Non-Absorbable Synthetic PolyesterGAT · Traditional | 03/03/1994SE |
| K931913 | Suture Non-Absorbable SilkGAP · Traditional | 03/03/1994SE |
Questions and answers
When was Stainless Steel Suture cleared by the FDA?
Stainless Steel Suture (K931915) received a 510(k) decision of Substantially Equivalent on March 3, 1994, 321 days after the submission was received.
What is the product code of K931915?
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.