Look Inc. 316L Stainless Steel Surgical Suture
FDA 510(k) K933686 · Look, Inc.
510(k) numberK933686
Submission
- Device name
- Look Inc. 316L Stainless Steel Surgical Suture
- Applicant
- Look, Inc.
Ada, OK, US - Received
- July 29, 1993
- Decision date
- December 23, 1993
- 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
Other 510(k)s with product code GAQ
| 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 |
|---|---|---|
| K943949 | Polyviolene Surgicl SutureGAT · Traditional | 11/10/1994SN |
| K926586 | Revised Labeling for Chromic and Plain Gut SuturesGAL · Traditional | 12/22/1993SE |
| K926588 | Revised Labeling for Polypropylene SutureGAW · Traditional | 12/17/1993SE |
| K926587 | Revised Labeling for Nylon Suture (Polyamide)GAR · Traditional | 12/17/1993SE |
| K926168 | Silk Sutures-Revised LabelingGAR · Traditional | 12/17/1993SE |
| K926167 | Polyviolene Suture-Revised LabelingGAT · Traditional | 12/17/1993SE |
| K913530 | Look ViscodissectorHQC · Traditional | 10/21/1991SE |
| K903029 | Sterile Black Monofilament Nylon Non-Absor. SutureGAR · Traditional | 10/25/1990SE |
| K903584 | Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional | 10/11/1990SE |
| K904054 | Polyviolene(Tm) SutureGAS · Traditional | 10/03/1990SE |
Questions and answers
When was Look Inc. 316L Stainless Steel Surgical Suture cleared by the FDA?
Look Inc. 316L Stainless Steel Surgical Suture (K933686) received a 510(k) decision of Substantially Equivalent on December 23, 1993, 147 days after the submission was received.
What is the product code of K933686?
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.