Medical Device Manufacturer · US , Austin , TX

Apollo Endosurgery, Inc.

12 submissions · 10 cleared · Since 2008
12
Total
10
Cleared
1
Denied

Apollo Endosurgery, Inc. — FDA 510(k) Submissions

Apollo Endosurgery, Inc. has submitted 12 FDA 510(k) premarket notifications since 2008, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Endoscopic Tissue Approximation Device, Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss, Endoscopic Access Overtube, Gastroenterology-urology, Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Forceps, Biopsy, Electric . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Apollo ESG NXT System, Apollo REVISE NXT System
K232544 · QTD Endoscopic Suturing... · Gastroenterology & Urology
Sep 2023 27d
OverStitch NXT Endoscopic Suturing System
K231553 · OCW Endoscopic Tissue... · General & Plastic Surgery
Jun 2023 30d
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
DEN210045 · QTD Endoscopic Suturing... · Gastroenterology & Urology
Jul 2022 285d
OverStitch Sx Endoscopic Suturing System
K210266 · OCW Endoscopic Tissue... · General & Plastic Surgery
Mar 2021 29d
X-Tack Endoscopic HeliX Tacking System
K201808 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Dec 2020 167d
OverStitch SX Endoscopic Suturing System (ESS)
K171886 · OCW Endoscopic Tissue... · General & Plastic Surgery
Nov 2017 142d
OVERTUBE ENDOSCOPIC ACCESS SYSTEM
K122270 · FED Endoscopic Access... · Gastroenterology & Urology
Sep 2012 60d
SUMO ACCESS AND TISSUE RESECTION SYSTEM
K103155 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Oct 2011 367d
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
K082102 · FED Endoscopic Access... · Gastroenterology & Urology
Jun 2010 689d
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
K090583 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Jun 2009 114d
ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
K082114 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Dec 2008 144d
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
K081853 · OCW Endoscopic Tissue... · General & Plastic Surgery
Aug 2008 49d
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