GAW — Suture, Nonabsorbable, Synthetic, Polypropylene Class II
FDA Device Classification
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 |
|---|
| 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 |
| K133356 | ethicon | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | December 6, 2013 |