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510(k) K024091

Device
SILK SUTURES
Applicant
AUROLAB
510(k) number
K024091
Product code
GAP  
Decision
Substantially Equivalent (SESE)
Decision date
2003-02-28
Date received
2002-12-11
Regulation
878.5030
Classification name
Suture, Nonabsorbable, Silk
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL G PRICE
Address
6441 Enterprise Ln. Suite 214 Madison WI US 53719 53719

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241486Sofsilk™ Coated Braided Silk SutureCovidien2024-12-03
K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.2024-10-18
K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.2024-01-16
K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.2023-07-31
K180701SafePath Suturing SystemSafepath Medical, Inc.2018-06-25
K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.2017-10-20
K162396SILK Surgical SutureTeleflexmedical, Inc.2016-11-23
K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.2016-05-31
K080684WG-SURGICAL SUTURES WITH NEEDLEFoosin Medical Supplies, Inc.2008-06-09
K071111NON-ABSORBABLE SILK SUTUREArrow Intl., Inc.2007-07-17
K053638MANI NEEDLE & SUTURE PACK (SILK)Mani, Inc.2006-05-19
K041514TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURESutures India Private Limited2005-06-03
K042282UNISILKUnited Medical Industries Co. , Ltd.2004-12-01
K023029DEMETECH SILK NONABSORBABLE SUTUREDemetech Corp.2002-11-25
K020901SERRALSILKSerral, S.A. DE C.V.2002-04-26

Legacy Summary#

summary

FDA Review#

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