QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Suture, Absorbable, Synthetic, Polyglycolic Acid

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 Monoderm Knotless Tissue-closure Device, Variable Loop Design.

Pre-market Notification Details

Device IDK122898
510k NumberK122898
Device Name:QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
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 CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-21
Decision Date2012-10-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10848782030603 K122898 000
10848782020031 K122898 000
10848782020093 K122898 000
10848782020116 K122898 000
10848782020345 K122898 000
10848782020406 K122898 000
10848782020420 K122898 000
10848782020482 K122898 000
10848782020505 K122898 000
10848782020543 K122898 000
10848782030597 K122898 000
10848782020017 K122898 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.