Cleared Traditional

GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00

K082102 · Apollo Endosurgery, Inc. · Gastroenterology & Urology

Jun 2010

Decision

689d

Days

Class 2

Risk

About This 510(k) Submission

K082102 is an FDA 510(k) clearance for the GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00, a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Cleared decision on June 14, 2010, 689 days after receiving the submission on July 25, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K082102 FDA.gov
FDA Decision	Cleared SESU
Date Received	July 25, 2008
Decision Date	June 14, 2010
Days to Decision	689 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FED — Endoscopic Access Overtube, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.