Cleared Traditional

Stryker ProCinch Adjustable Loop Device

K210078 · Stryker Endoscopy · Orthopedic
Mar 2021
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K210078 is an FDA 510(k) clearance for the Stryker ProCinch Adjustable Loop Device, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on March 11, 2021, 58 days after receiving the submission on January 12, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K210078 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2021
Decision Date March 11, 2021
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040