Cleared Traditional

ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00

K082114 · Apollo Endosurgery, Inc. · Gastroenterology & Urology
Dec 2008
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K082114 is an FDA 510(k) clearance for the ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Cleared decision on December 19, 2008, 144 days after receiving the submission on July 28, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K082114 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2008
Decision Date December 19, 2008
Days to Decision 144 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

Similar Devices — KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 186
Vanquish Water Vapor Ablation Device
K252388 · Francis Medical, Inc. · Nov 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889 · Olympus Medical Systems Corporation · Nov 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
K250945 · Olympus Medical Systems Corp. · Oct 2025
Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
K250351 · Olympus Medical Systems Corporation · Oct 2025
SureTome? SW Sphincterotome with DomeTip
K251104 · Wilson Cook Medical · Sep 2025
Aqua Medical RF Vapor Ablation System
K251226 · Aqua Medical, Inc. · Aug 2025