GAP · Suture, Nonabsorbable, Silk
General, Plastic Surgery · 21 CFR 878.5030 · Class 2
Overview
| Product Code | GAP |
|---|---|
| Device Name | Suture, Nonabsorbable, Silk |
| Regulation | 21 CFR 878.5030 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
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 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241486 | Sofsilk Coated Braided Silk Suture | Covidien | Dec 3, 2024 | SESE |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture | Safepath Medical, Inc. | Oct 18, 2024 | SESE |
| K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | Jan 16, 2024 | SESE |
| K221767 | Surgical Sutures with or without Needle | Huaian Seamen Medical Technology Co., Ltd. | Jul 31, 2023 | SESE |
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | Jun 25, 2018 | SESE |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | M/s. Meril Endo Surgery Private Limited. | Oct 20, 2017 | SESE |
| K162396 | SILK Surgical Suture | Teleflexmedical, Inc. | Nov 23, 2016 | SESE |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | M/s. Meril Endo Surgery Private Limited. | May 31, 2016 | SESE |
| K080684 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | Jun 9, 2008 | SESE |
| K071111 | NON-ABSORBABLE SILK SUTURE | Arrow Intl., Inc. | Jul 17, 2007 | SESE |
| K053638 | MANI NEEDLE & SUTURE PACK (SILK) | Mani, Inc. | May 19, 2006 | SESE |
| K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | Sutures India Private Limited | Jun 3, 2005 | SESE |
| K042282 | UNISILK | United Medical Industries Co. , Ltd. | Dec 1, 2004 | SESE |
| K024091 | SILK SUTURES | Aurolab | Feb 28, 2003 | SESE |
| K023029 | DEMETECH SILK NONABSORBABLE SUTURE | Demetech Corp. | Nov 25, 2002 | SESE |
| K020901 | SERRALSILK | Serral, S.A. DE C.V. | Apr 26, 2002 | SESE |
| K012124 | MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP | Johnson & Johnson Medical (China) , Ltd. | Sep 19, 2001 | SESE |
| K003001 | GRAMS SILK NONABSORBABLE SUTURE | Gramsmed, LLC | Dec 15, 2000 | SESE |
| K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | Cp Medical | Jun 23, 2000 | SN |
| K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | Apr 28, 2000 | SESE |
Top Applicants
- United States Surgical, A Division of Tyco Healthc — 5 clearances
- Surgical Specialties, Inc. — 2 clearances
- Safepath Medical, Inc. — 2 clearances
- M/s. Meril Endo Surgery Private Limited. — 2 clearances
- Visitec Co. — 1 clearance
