Cleared Special

OverStitch Sx Endoscopic Suturing System

K210266 · Apollo Endosurgery, Inc. · General & Plastic Surgery

Mar 2021

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K210266 is an FDA 510(k) clearance for the OverStitch Sx Endoscopic Suturing System, a Endoscopic Tissue Approximation Device (Class II — Special Controls, product code OCW), submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Cleared decision on March 2, 2021, 29 days after receiving the submission on February 1, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K210266 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2021
Decision Date	March 02, 2021
Days to Decision	29 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OCW — Endoscopic Tissue Approximation Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.