QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Suture, Nonabsorbable, Synthetic, Polypropylene

SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

The following data is part of a premarket notification filed by Surgical Specialties Corp. Dba Angiotech with the FDA for Quill Polypropylene Knotless Tissue-closure Device, Variable Loop Design.

Pre-market Notification Details

Device IDK130078
510k NumberK130078
Device Name:QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading,  PA  19606
ContactKirsten Stowell
CorrespondentKirsten Stowell
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading,  PA  19606
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-14
Decision Date2013-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10848782020550 K130078 000
20705031228129 K130078 000

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