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Apollo Endosurgery Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
14
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2743-2018Class IIApollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists oNovember 22, 2017
Z-2732-2014Class IILAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product wAugust 15, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K232544Apollo ESG NXT System, Apollo REVISE NXT SystemSeptember 18, 2023
K231553OverStitch NXT Endoscopic Suturing SystemJune 29, 2023
DEN210045APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX SystemJuly 12, 2022
K210266OverStitch Sx Endoscopic Suturing SystemMarch 2, 2021
K201808X-Tack Endoscopic HeliX Tacking SystemDecember 15, 2020
K191439OverStitch 2-0 Polypropylene SutureAugust 29, 2019
K181141OverStitch Endoscopic Suturing System and AccessoriesJune 27, 2018
K171886OverStitch SX Endoscopic Suturing System (ESS)November 15, 2017
K122270OVERTUBE ENDOSCOPIC ACCESS SYSTEMSeptember 28, 2012
K103155SUMO ACCESS AND TISSUE RESECTION SYSTEMOctober 28, 2011
K082102GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00June 14, 2010
K090583ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165June 26, 2009
K082114ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00December 19, 2008
K081853OVERSTITCH ENDOSCOPIC SUTURE SYSTEMAugust 18, 2008