Cleared Special

OverStitch NXT Endoscopic Suturing System

K231553 · Apollo Endosurgery, Inc. · General & Plastic Surgery

Jun 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K231553 is an FDA 510(k) clearance for the OverStitch NXT 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 June 29, 2023, 30 days after receiving the submission on May 30, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K231553 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2023
Decision Date	June 29, 2023
Days to Decision	30 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.