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510(k) K043591

Device
FEATHERLIFT EXTENDED APTOS THREAD
Applicant
KMI KOLSTER METHODS, INC.
510(k) number
K043591
Product code
GAW  
Decision
Substantially Equivalent (SESE)
Decision date
2005-03-04
Date received
2004-12-28
Regulation
878.5010
Classification name
Suture, Nonabsorbable, Synthetic, Polypropylene
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KEITH DAVIS
Address
3185 Palisades Dr. Corona CA US 92882 92882

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.2026-03-27
K233355Cypris eXact Suturing SystemCypris Medical2024-01-12
K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.2023-09-14
K221280VessealLydus Medical , Ltd.2022-12-09
K211178DURAMESH Mesh SutureMsi2022-09-02
K192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC2020-08-27
K193530Deklene MAXXTeleflex Medical2020-03-19
K191299Silhouette Featherlift / Silhouette LiftSilhouette Lift, Inc.2019-06-14
K173747REXLENESm Eng Co., Ltd.2018-12-21
K180321Aesculap Optilene Nonabsorbable SutureAesculap, Inc.2018-03-07
K173644Gazelle Polypropylene Suture and Delivery DeviceDura Tap, LLC2018-02-15
K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A.2017-08-29
K171005Silhouette FeatherliftSilhouette Lift, Inc.2017-05-03
K162617NobleStitch ELNobles Medical Technologies Ii, Inc.2017-04-06
K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions2016-09-15

Legacy Summary#

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FDA Review#

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