GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
General, Plastic Surgery · 21 CFR 878.4495 · Class 2
Overview
| Product Code | GAQ |
|---|---|
| Device Name | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Regulation | 21 CFR 878.4495 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.
Classification Rationale
Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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 device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203855 | CoNextions TR Tendon Repair System | Conextions Medical | Apr 22, 2022 | SESE |
| K193209 | Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. | Feb 19, 2020 | SESE |
| K172146 | MERISTEEL | M/s. Meril Endo Surgery Private Limited. | Feb 1, 2018 | SESE |
| K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | ETHICON, Inc. | Nov 1, 2017 | SESE |
| K141007 | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE | Demetech Corp. | Sep 25, 2014 | SESE |
| K140127 | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP | Pontis Orthopaedics, LLC | May 28, 2014 | SESE |
| K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 | Core Essence Orthopaedics, LLC | Dec 24, 2008 | SESE |
| K082828 | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE | Suturtek Incorporated | Oct 14, 2008 | SESE |
| K063603 | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 | Suturtek Incorporated | Feb 7, 2007 | SESE |
| K042606 | MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | May 27, 2005 | SESE |
| K041333 | SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | Aug 27, 2004 | SESE |
| K032468 | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE | Suturtek Incorporated | Sep 23, 2003 | SESE |
| K023594 | TENO FIX | Ortheon Medical, LLC | May 15, 2003 | SESE |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Cp Medical | Mar 28, 2003 | SESE |
| K023411 | STEELEX STERNUM SET | Aesculap, Inc. | Dec 19, 2002 | SESE |
| K022777 | MANUAL TOUCHE SYSTEM | Onux Medical, Inc. | Nov 19, 2002 | SESE |
| K013059 | STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) | Stony Brook Surgical Innovations, Inc. | Oct 22, 2001 | SESE |
| K991073 | ACIER SUTURES | Cardio Thoracic Systems | Jul 30, 1999 | SESE |
| K984151 | STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP | Mill Pond, Inc. | Apr 28, 1999 | SESE |
| K955723 | STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) | Davis & Geck, Inc. | Feb 27, 1996 | SN |
Top Applicants
- ETHICON, Inc. — 3 clearances
- Suturtek Incorporated — 3 clearances
- Synthes (Usa) — 2 clearances
- Aesculap, Inc. — 1 clearance
- American Cyanamid Co. — 1 clearance
