Cleared Special

StitchKit

K211792 · Origami Surgical Inc . · General & Plastic Surgery
Jul 2021
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K211792 is an FDA 510(k) clearance for the StitchKit, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Origami Surgical Inc . (Madison, US). The FDA issued a Cleared decision on July 16, 2021, 36 days after receiving the submission on June 10, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.

Submission Details

510(k) Number K211792 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2021
Decision Date July 16, 2021
Days to Decision 36 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4493

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