Cleared Traditional

OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

K081853 · Apollo Endosurgery, Inc. · General & Plastic Surgery

Aug 2008

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K081853 is an FDA 510(k) clearance for the OVERSTITCH ENDOSCOPIC SUTURE 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 August 18, 2008, 49 days after receiving the submission on June 30, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K081853 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2008
Decision Date	August 18, 2008
Days to Decision	49 days
Submission Type	Traditional
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.