GAR · Suture, Nonabsorbable, Synthetic, Polyamide
General, Plastic Surgery · 21 CFR 878.5020 · Class 2
Overview
| Product Code | GAR |
|---|---|
| Device Name | Suture, Nonabsorbable, Synthetic, Polyamide |
| Regulation | 21 CFR 878.5020 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220980 | Tissue Approximation System (TAS) | Tas Medical, Inc. | Jul 5, 2023 | SESE |
| K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | Mar 31, 2022 | SESE |
| K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | Dec 22, 2021 | SESE |
| K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | May 29, 2020 | SESE |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | Mar 2, 2017 | SESE |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | Feb 17, 2016 | SESE |
| K152795 | RiverLon (Nylon) Suture | Riverpoint Medical | Oct 28, 2015 | SESE |
| K123034 | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED | Unilene Sac | May 28, 2013 | SESE |
| K081366 | KUMAR T-ANCHORS HERNIA SET | Nashville Surgical Instruments | Jul 15, 2008 | SESE |
| K060471 | FSSB NYLON SURGICAL SUTURES | Fssb Chirurgische Nadeln GmbH | Jul 26, 2006 | SESE |
| K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | Mani, Inc. | May 19, 2006 | SESE |
| K060528 | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE | Aesculap, Inc. | Mar 28, 2006 | SESE |
| K052900 | QUILL NONABSORBABLE NYLON BARBED SUTURE | Quill Medical, Inc. | Nov 28, 2005 | SESE |
| K052482 | ARTELON SURGICAL SUTURE | Artimplant AB | Oct 17, 2005 | SESE |
| K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | Sutures India Private Limited | Jun 2, 2005 | SESE |
| K042284 | UNIMIDE | United Medical Industries Co. , Ltd. | Dec 3, 2004 | SESE |
| K042367 | NYLON THREADED NEEDLE | Aros Surgical Instruments Corp. | Oct 14, 2004 | SESE |
| K032160 | ARTELON SURGICAL SUTURE | Artimplant AB | Nov 17, 2003 | SESE |
| K031531 | S&T MICROSURGICAL SUTURE | S & T AG | Sep 23, 2003 | SESE |
| K030177 | ORLON NONABSORABLE SURGICAL SUTURE USP | Sri Orion Pharmaceuticals & Sutures | Jul 21, 2003 | SESE |
Top Applicants
- S. Jackson, Inc. — 4 clearances
- Aesculap, Inc. — 3 clearances
- Look, Inc. — 3 clearances
- Sutures , Ltd. — 3 clearances
- United States Surgical, A Division of Tyco Healthc — 3 clearances
