Stryker ProCinch Adjustable Loop Device

Fastener, Fixation, Nondegradable, Soft Tissue

Stryker Endoscopy

The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Procinch Adjustable Loop Device.

Pre-market Notification Details

Device IDK210078
510k NumberK210078
Device Name:Stryker ProCinch Adjustable Loop Device
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Stryker Endoscopy 5900 Optical Court San Jose,  CA  95138
ContactVictoria Milich
CorrespondentVictoria Milich
Stryker Endoscopy 5900 Optical Court San Jose,  CA  95138
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-12
Decision Date2021-03-11

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