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 IDK123409
510k NumberK123409
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 Received2012-11-05
Decision Date2012-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10848782020390 K123409 000
10848782020079 K123409 000
10848782020239 K123409 000
10848782020253 K123409 000
10848782020277 K123409 000
10848782020291 K123409 000
10848782020314 K123409 000
10848782020338 K123409 000
10848782020352 K123409 000
10848782020369 K123409 000
10848782020376 K123409 000
10848782020383 K123409 000
10848782020055 K123409 000

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