Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4495](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4495) → GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile # GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile _General, Plastic Surgery · 21 CFR 878.4495 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ ## Overview - **Product Code:** GAQ - **Device Name:** Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile - **Regulation:** [21 CFR 878.4495](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4495) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K203855.md) | CoNextions TR Tendon Repair System | Conextions Medical | Apr 22, 2022 | SESE | | [K193209](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K193209.md) | Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. | Feb 19, 2020 | SESE | | [K172146](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K172146.md) | MERISTEEL | M/s. Meril Endo Surgery Private Limited. | Feb 1, 2018 | SESE | | [K170767](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K170767.md) | Surgical Stainless Steel Suture, Stainless Steel Suture | ETHICON, Inc. | Nov 1, 2017 | SESE | | [K141007](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K141007.md) | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE | Demetech Corp. | Sep 25, 2014 | SESE | | [K140127](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K140127.md) | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP | Pontis Orthopaedics, LLC | May 28, 2014 | SESE | | [K081060](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K081060.md) | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 | Core Essence Orthopaedics, LLC | Dec 24, 2008 | SESE | | [K082828](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K082828.md) | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE | Suturtek Incorporated | Oct 14, 2008 | SESE | | [K063603](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K063603.md) | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 | Suturtek Incorporated | Feb 7, 2007 | SESE | | [K042606](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K042606.md) | MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | May 27, 2005 | SESE | | [K041333](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K041333.md) | SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | Aug 27, 2004 | SESE | | [K032468](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K032468.md) | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE | Suturtek Incorporated | Sep 23, 2003 | SESE | | [K023594](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K023594.md) | TENO FIX | Ortheon Medical, LLC | May 15, 2003 | SESE | | [K030351](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K030351.md) | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Cp Medical | Mar 28, 2003 | SESE | | [K023411](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K023411.md) | STEELEX STERNUM SET | Aesculap, Inc. | Dec 19, 2002 | SESE | | [K022777](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K022777.md) | MANUAL TOUCHE SYSTEM | Onux Medical, Inc. | Nov 19, 2002 | SESE | | [K013059](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K013059.md) | STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) | Stony Brook Surgical Innovations, Inc. | Oct 22, 2001 | SESE | | [K991073](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K991073.md) | ACIER SUTURES | Cardio Thoracic Systems | Jul 30, 1999 | SESE | | [K984151](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K984151.md) | STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP | Mill Pond, Inc. | Apr 28, 1999 | SESE | | [K955723](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K955723.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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