Surgical Suture, Nonabsorable Stainless Steel
FDA 510(k) K930740 · Deknatel, Inc.
510(k) numberK930740
Submission
- Device name
- Surgical Suture, Nonabsorable Stainless Steel
- Applicant
- Deknatel, Inc.
San Jose-Heredia, CR - Received
- February 12, 1993
- Decision date
- July 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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|---|---|---|---|
| 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 |
|---|---|---|
| K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemCAC · Traditional | 04/22/1997SE |
| K962683 | Snowden-Pencer Computerized High Flow InsufflatorHIF · Traditional | 01/10/1997SE |
| K964070 | Deknatel DSP Pleur-Evac Autotransfusion Blood Recovery BagCAC · Traditional | 12/31/1996SE |
| K963098 | Pleur-Evac Shara Plus Model S-2150/CONTINUOUS Reinfusion Autotransfusion SYSTEM(S-100)CAC · Traditional | 11/08/1996SE |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional | 08/28/1996SE |
| K925243 | Deknatel(Tm) Pleur-Evac(R) Thoracic CatheterGBX · Traditional | 07/27/1994SE |
| K930739 | Sutures Polyprop., Polyetheline, Nylon & SilkGAP · Traditional | 07/26/1994SE |
| K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcGAL · Traditional | 07/26/1994SE |
| K926338 | Pleur-Evac Cardiotomy Reservoir # CR-9400 & 9400FCAC · Traditional | 07/26/1994SE |
| K931106 | Biosurge(Tm) Synchronous Autotrans Procedure KitCAC · Traditional | 10/06/1993SE |
Questions and answers
When was Surgical Suture, Nonabsorable Stainless Steel cleared by the FDA?
Surgical Suture, Nonabsorable Stainless Steel (K930740) received a 510(k) decision of Substantially Equivalent on July 26, 1994, 529 days after the submission was received.
What is the product code of K930740?
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.