STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device

Suture, Absorbable, Synthetic, Polyglycolic Acid

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Stratafix Spiral Monocryl Knotless Tissue Control Device, Stratafix Spiral Monocryl Plus Knotless Tissue Control Device.

Pre-market Notification Details

Device IDK151200
510k NumberK151200
Device Name:STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville,  NJ  08876 -0151
ContactDonna Marshall
CorrespondentDonna Marshall
ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville,  NJ  08876 -0151
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2015-05-05
Decision Date2015-08-13
Summary:summary

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