Cleared Traditional

StitchKit

K191317 · Origami Surgical · General & Plastic Surgery

Jul 2019

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K191317 is an FDA 510(k) clearance for the StitchKit, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Origami Surgical (Madison, US). The FDA issued a Cleared decision on July 12, 2019, 58 days after receiving the submission on May 15, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.

Submission Details

510(k) Number	K191317 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2019
Decision Date	July 12, 2019
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	NBY — Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5035