Cleared Traditional

ProCinch Adjustable Loop Device

K150416 · Stryker Endoscopy · Orthopedic
Apr 2015
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K150416 is an FDA 510(k) clearance for the ProCinch Adjustable Loop Device, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on April 17, 2015, 58 days after receiving the submission on February 18, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K150416 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2015
Decision Date April 17, 2015
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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