Suture, Nonabsorbable, Synthetic, Polyester
General, Plastic Surgery · 21 CFR 878.5000
Recent MDR events
825 adverse event reports on file
- COR-KNOT MINI COMBO KITJun 23, 2026MalfunctionLsi Solutions Inc.MW5189829
- ALCON CLOSURE SYSTEM (ACS), POLYESTERJun 5, 2025MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2025-00648
- LUPINE BR W/ORTHCRDMar 19, 2025MalfunctionDepuy Mitek Llc Us1221934-2025-00978
- ALCON CLOSURE SYSTEM (ACS), POLYESTERMar 14, 2025InjuryAlcon Research, Llc - Alcon Precision Device2523835-2025-00277
- ALCON CLOSURE SYSTEM (ACS), POLYESTERJul 18, 2024MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2024-01749
- FAST-FIX DEVSep 30, 2020MalfunctionSmith & Nephew, Inc.1219602-2020-01493
- COR-KNOTOct 5, 2018InjuryLsi Solutions, Inc.MW5080414
- COR-KNOTOct 5, 2018InjuryLsi Solutions, Inc.MW5080415
- COR-KNOTFeb 23, 2018MalfunctionLsi Solutions Inc.7291636
- COR-KNOT MINI DEVICEOct 26, 2016MalfunctionLsi SolutionsMW5065658
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
60 firms currently registered for this product code
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
Teleflex Medical Llc
Morrisville, NC, US
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Teleflex Medical Llc
MANSFIELD, MA, US
Healthium Medtech Limited
BANGALORE Karnataka, IN
Isomedix Operations Inc.
S Plainfield, NJ, US
Visionary Medical Supplies, Inc.
Madison, WI, US
Internacional Farmaceutica, S.a. De C.v.
LERMA Mexico, MX
Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International Inc.)
BIRMINGHAM, AL, US
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Lynx Medical Pennsylvania
ERIE, PA, US
Synthes (usa) Products Llc
West Chester, PA, US
Linvatec Corporation
LARGO, FL, US
Medos International Sarl
Le Locle Neuchatel, CH
Arthrex Manufacturing Inc.
Pendleton, SC, US
Zimmer Biomet Korea Ltd.
Seoul, KR
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Endure Industries, Inc.
Homer, NY, US
Akshar Gamma Steriles Llp
THANE Maharashtra, IN
Tribe Medical Group
London Ontario, CA
Lsi Solutions Inc.
VICTOR, NY, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
510(k) clearances
17 clearances for this product code
- Lsi Solutions, Inc.Nov 24, 2020
K203120 · RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
- Lsi SolutionsNov 24, 2020
K203081 · RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
- Arthrex, Inc.Jul 30, 2010
K091018 · ARTHREX BIOWIRE
- Smith & Nephew, Inc.Oct 23, 2000
K002261 · MR-III
- Phoenix Biomedical Corp.Feb 9, 1996
K953128 · SUTURE CORD
- Mitek Surgical Products, Inc.Dec 30, 1992
K923161 · BRAIDED POLYESTER SUTURE MATERIAL
- Promedica Products, Inc.Aug 12, 1992
K913101 · PETERS CARDIOFLON(TM) SUTURE
- Mitek Surgical Products, Inc.Feb 3, 1992
K915089 · MITEK QUICKANCHOR(TM), MODIFICATION