Panels › General, Plastic Surgery › Product code GAQ · Class 2
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Regulation 878.4495
0510(k)s in 12 months (32 all time)
2recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in GAQ
| Company | 510(k)s | Recalls |
|---|---|---|
| ETHICON, Inc. | 3 | 4 |
| Suturtek Incorporated | 3 | 0 |
| Teleflex Medical | 0 | 3 |
| Synthes (Usa) | 2 | 0 |
| Aesculap, Inc. | 1 | 0 |
| American Cyanamid Co. | 1 | 0 |
| Cardio Thoracic Systems | 1 | 0 |
| Conextions Medical | 1 | 0 |
| Core Essence Orthopaedics, LLC | 1 | 0 |
| Cp Medical | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 22, 2022 | K203855 | CoNextions TR Tendon Repair System Conextions Medical | GAQ |
| Feb 19, 2020 | K193209 | Wego-Stainless Steel Foosin Medical Supplies Inc., Ltd., CN | GAQ |
| Feb 1, 2018 | K172146 | MERISTEEL M/s. Meril Endo Surgery Private Limited., IN | GAQ |
| Nov 1, 2017 | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture ETHICON, Inc. | GAQ |
| Sep 25, 2014 | K141007 | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE Demetech Corp. | GAQ |
| May 28, 2014 | K140127 | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP Pontis Orthopaedics, LLC | GAQ |
| Dec 24, 2008 | K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 Core Essence Orthopaedics, LLC | GAQ |
| Oct 14, 2008 | K082828 | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE Suturtek Incorporated | GAQ |
| Feb 7, 2007 | K063603 | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 Suturtek Incorporated | GAQ |
| May 27, 2005 | K042606 | MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE Synthes (Usa) | GAQ |
| Aug 27, 2004 | K041333 | SYNTHES (USA) TITANIUM WIRE Synthes (Usa) | GAQ |
| Sep 23, 2003 | K032468 | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE Suturtek Incorporated | GAQ |
| May 15, 2003 | K023594 | TENO FIX Ortheon Medical, LLC | GAQ |
| Mar 28, 2003 | K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE Cp Medical | GAQ |
| Dec 19, 2002 | K023411 | STEELEX STERNUM SET Aesculap, Inc. | GAQ |
| Nov 19, 2002 | K022777 | MANUAL TOUCHE SYSTEM Onux Medical, Inc. | GAQ |
| Oct 22, 2001 | K013059 | STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) Stony Brook Surgical Innovations, Inc. | GAQ |
| Jul 30, 1999 | K991073 | ACIER SUTURES Cardio Thoracic Systems | GAQ |
| Apr 28, 1999 | K984151 | STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP Mill Pond, Inc. | GAQ |
| Feb 27, 1996 | K955723 | STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) Davis & Geck, Inc. | GAQ |
| Jan 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK ETHICON, Inc. | GAQ |
| Jul 26, 1994 | K930740 | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL Deknatel, Inc., CR | GAQ |
| Mar 3, 1994 | K931915 | STAINLESS STEEL SUTURE Surgimetrics International, Ltd. | GAQ |
| Jan 7, 1994 | K931271 | ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE ETHICON, Inc. | GAQ |
| Dec 23, 1993 | K933686 | LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE Look, Inc. | GAQ |
| Dec 17, 1993 | K930992 | FLEXON AND STAINLESS STEEL SUTURES American Cyanamid Co. | GAQ |
| Dec 17, 1993 | K930940 | LUKENS STAINLESS STEEL SURGICAL SUTURE Lukens Medical Corp. | GAQ |
| Dec 4, 1991 | K913185 | STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT Internacional Farmaceutica, S.A. DE C.V. | GAQ |
| Sep 16, 1991 | K913155 | LEG URINAL Ezmt Valve Co., Inc. | GAQ |
| May 6, 1991 | K910067 | PTI STERNAL CLOSURE WIRE SUTURE Pioneering Technologies, Inc. | GAQ |
| Nov 17, 1987 | K873645 | STAINLESS 22-13-5 SUTURE WIRE Zimmer, Inc. | GAQ |
| Jun 30, 1987 | K865038 | SURGISTEEL Sutures , Ltd., GB | GAQ |
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