FDA.reportPublic FDA data

510(k) K231277

Device
TissueStat
Applicant
Durastat, LLC
510(k) number
K231277
Product code
NBY
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-09
Date received
2023-05-03
Regulation
878.5035
Classification name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Adam Azzara
Address
1101 E. 6th St. Unit B Austin TX US 78702 78702

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NBY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures2019-09-04
K180992BiotexPurgo Biologics, Inc.2019-07-16
K191317StitchKitOrigami Surgical2019-07-12
K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation2018-10-11
K180630PTFE SURGICAL SUTUREOmnia Spa2018-04-06
K173922C-PTFETM Surgical SutureCp Medical, Inc.2018-03-26
K173335Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC2018-02-08
K170842WEGO-PTFEFoosin Medical Supplies Inc., Ltd.2017-07-31
K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures2017-06-21
K163639LS-5 ePTFE SutureLsi Solutions2017-06-02
K160744LOOK PTFE SutureSurgical Specialties Corporation2016-07-13
K140415MONOTEXRiverpoint Medical2014-03-26
K132464PTFE SURGICAL SUTUREOmnia Spa2014-02-12
K123811STITCHKITOrigami Surgical, LLC2013-09-05
K072076CYTOPLAST PTFE SUTUREOsteogenics Biomedical, Inc.2007-10-31