GAW — Suture, Nonabsorbable, Synthetic, Polypropylene Class II
FDA product code GAW covers "Suture, Nonabsorbable, Synthetic, Polypropylene", a Class II medical device regulated under 21 CFR 878.5010. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAW
- Device Class
- Class II
- Regulation Number
- 878.5010
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253572 | ethicon | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATA | March 27, 2026 |
| K233355 | cypris medical | Cypris eXact Suturing System | January 12, 2024 |
| K230746 | shandong haidike medical products co | Non absorbable Surgical Polypropylene Suture | September 14, 2023 |
| K221280 | lydus medical | Vesseal | December 9, 2022 |
| K211178 | msi | DURAMESH Mesh Suture | September 2, 2022 |
| K192953 | aptos | APTOS Threads Polypropylene Surgical Sutures | August 27, 2020 |
| K193530 | teleflex medical | Deklene MAXX | March 19, 2020 |
| K191299 | silhouette lift | Silhouette Featherlift / Silhouette Lift | June 14, 2019 |
| K173747 | sm eng co | REXLENE | December 21, 2018 |
| K180321 | aesculap | Aesculap Optilene Nonabsorbable Suture | March 7, 2018 |
| K173644 | dura tap | Gazelle Polypropylene Suture and Delivery Device | February 15, 2018 |
| K171039 | assut europe | Assut Filbloc Permanent Sutures | August 29, 2017 |
| K171005 | silhouette lift | Silhouette Featherlift | May 3, 2017 |
| K162617 | nobles medical technologies ii | NobleStitch EL | April 6, 2017 |
| K160529 | lsi soultions | Pledgeted COR-SUTURE QUICK LOAD | September 15, 2016 |
| K143582 | resorba medical | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL | October 29, 2015 |
| K151112 | angiotech | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | September 10, 2015 |
| K141206 | edwards lifesciences | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM | January 16, 2015 |
| K142639 | origami surgical | StitchKit | December 16, 2014 |
| K133890 | aesculap | AESCULAP OPTILENE NONABSORBABLE SUTURE | July 15, 2014 |