GAW · Suture, Nonabsorbable, Synthetic, Polypropylene
General, Plastic Surgery · 21 CFR 878.5010 · Class 2
Overview
| Product Code | GAW |
|---|---|
| Device Name | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Regulation | 21 CFR 878.5010 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 86)
Showing 20 most recent of 86 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | Mar 27, 2026 | SESE |
| K233355 | Cypris eXact Suturing System | Cypris Medical | Jan 12, 2024 | SESE |
| K230746 | Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. | Sep 14, 2023 | SESE |
| K221280 | Vesseal | Lydus Medical , Ltd. | Dec 9, 2022 | SESE |
| K211178 | DURAMESH Mesh Suture | Msi | Sep 2, 2022 | SESE |
| K192953 | APTOS Threads Polypropylene Surgical Sutures | Aptos, LLC | Aug 27, 2020 | SESE |
| K193530 | Deklene MAXX | Teleflex Medical | Mar 19, 2020 | SESE |
| K191299 | Silhouette Featherlift / Silhouette Lift | Silhouette Lift, Inc. | Jun 14, 2019 | SESE |
| K173747 | REXLENE | Sm Eng Co., Ltd. | Dec 21, 2018 | SESE |
| K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | Mar 7, 2018 | SESE |
| K173644 | Gazelle Polypropylene Suture and Delivery Device | Dura Tap, LLC | Feb 15, 2018 | SESE |
| K171039 | Assut Filbloc Permanent Sutures | Assut Europe S.P.A. | Aug 29, 2017 | SESE |
| K171005 | Silhouette Featherlift | Silhouette Lift, Inc. | May 3, 2017 | SESE |
| K162617 | NobleStitch EL | Nobles Medical Technologies Ii, Inc. | Apr 6, 2017 | SESU |
| K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | Sep 15, 2016 | SESE |
| K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL | Resorba Medical GmbH | Oct 29, 2015 | SESE |
| K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Angiotech | Sep 10, 2015 | SESE |
| K141206 | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM | Edwards Lifesciences, LLC | Jan 16, 2015 | SESE |
| K142639 | StitchKit | Origami Surgical, LLC | Dec 16, 2014 | SESE |
| K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Aesculap, Inc. | Jul 15, 2014 | SESE |
Top Applicants
- Axya Medical, Inc. — 5 clearances
- Surgical Specialties Corp — 5 clearances
- ETHICON, Inc. — 4 clearances
- Sutura, Inc. — 4 clearances
- Aesculap, Inc. — 3 clearances
