QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Suture, Absorbable, Synthetic, Polyglycolic Acid

SURGICAL SPECIALTIES CORPORATION

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

Pre-market Notification Details

Device IDK141778
510k NumberK141778
Device Name:QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SURGICAL SPECIALTIES CORPORATION 100 DENNIS DRIVE Reading,  PA  19606
ContactKirsten Stowell Franco
CorrespondentKirsten Stowell Franco
SURGICAL SPECIALTIES CORPORATION 100 DENNIS DRIVE Reading,  PA  19606
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-02
Decision Date2014-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10848782020536 K141778 000
10848782020529 K141778 000
10848782040060 K141778 000
10848782004772 K141778 000

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