FDA.reportPublic FDA data

510(k) K900531

Device
NONABSORBABLE NYLON SURGICAL SUTURE*
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
510(k) number
K900531
Product code
GAR  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1990-07-05
Date received
1990-02-05
Regulation
878.5020
Classification name
Suture, Nonabsorbable, Synthetic, Polyamide
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WALTER S HENNIG
Address
150 Glover Ave. Norwalk CT US 06856 06856

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220980Tissue Approximation System (TAS)Tas Medical, Inc.2023-07-05
K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures2022-03-31
K212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.2021-12-22
K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.2020-05-29
K161633REXLON, REXSILSm Eng Co., Ltd.2017-03-02
K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc.2016-02-17
K152795RiverLon (Nylon) SutureRiverpoint Medical2015-10-28
K123034VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMEDUnilene Sac2013-05-28
K081366KUMAR T-ANCHORS HERNIA SETNashville Surgical Instruments2008-07-15
K060471FSSB NYLON SURGICAL SUTURESFssb Chirurgische Nadeln GmbH2006-07-26
K053637MANI NEEDLE & SUTURE PACK (NYLON)Mani, Inc.2006-05-19
K060528AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTUREAesculap, Inc.2006-03-28
K052900QUILL NONABSORBABLE NYLON BARBED SUTUREQuill Medical, Inc.2005-11-28
K052482ARTELON SURGICAL SUTUREArtimplant AB2005-10-17
K041510TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURESutures India Private Limited2005-06-02

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases