Polyviolene Suture-Revised Labeling
FDA 510(k) K926167 · Look, Inc.
510(k) numberK926167
Submission
- Device name
- Polyviolene Suture-Revised Labeling
- Applicant
- Look, Inc.
Ada, OK, US - Received
- December 1, 1992
- Decision date
- December 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K943949 | Polyviolene Surgicl SutureGAT · Traditional | 11/10/1994SN |
| K933686 | Look Inc. 316L Stainless Steel Surgical SutureGAQ · Traditional | 12/23/1993SE |
| 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 |
| 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 Polyviolene Suture-Revised Labeling cleared by the FDA?
Polyviolene Suture-Revised Labeling (K926167) received a 510(k) decision of Substantially Equivalent on December 17, 1993, 381 days after the submission was received.
What is the product code of K926167?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.