GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile Class II
FDA product code GAQ covers "Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile", a Class II medical device regulated under 21 CFR 878.4495. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAQ
- Device Class
- Class II
- Regulation Number
- 878.4495
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203855 | conextions medical | CoNextions TR Tendon Repair System | April 22, 2022 |
| K193209 | foosin medical supplies inc | Wego-Stainless Steel | February 19, 2020 |
| K172146 | m/s. meril endo surgery private limited | MERISTEEL | February 1, 2018 |
| K170767 | ethicon | Surgical Stainless Steel Suture, Stainless Steel Suture | November 1, 2017 |
| K141007 | demetech | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE | September 25, 2014 |
| K140127 | pontis orthopaedics | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP | May 28, 2014 |
| K081060 | core essence orthopaedics | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 | December 24, 2008 |
| K082828 | suturtek incorporated | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE | October 14, 2008 |
| K063603 | suturtek incorporated | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 | February 7, 2007 |
| K042606 | synthes (usa) | MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE | May 27, 2005 |
| K041333 | synthes (usa) | SYNTHES (USA) TITANIUM WIRE | August 27, 2004 |
| K032468 | suturtek incorporated | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE | September 23, 2003 |
| K023594 | ortheon medical | TENO FIX | May 15, 2003 |
| K030351 | cp medical | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | March 28, 2003 |
| K023411 | aesculap | STEELEX STERNUM SET | December 19, 2002 |
| K022777 | onux medical | MANUAL TOUCHE SYSTEM | November 19, 2002 |
| K013059 | stony brook surgical innovations | STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) | October 22, 2001 |
| K991073 | cardio thoracic systems | ACIER SUTURES | July 30, 1999 |
| K984151 | mill pond | STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP | April 28, 1999 |
| K955723 | davis and geck | STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) | February 27, 1996 |