Apollo Endosurgery Inc
FDA Regulatory Profile
Apollo Endosurgery Inc appears in FDA public data with 2 recalls, 14 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2743-2018, Class II) was initiated on November 22, 2017. Its most recent 510(k) clearance was granted on September 18, 2023.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 14
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2743-2018 | Class II | Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists o | November 22, 2017 |
| Z-2732-2014 | Class II | LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product w | August 15, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | September 18, 2023 |
| K231553 | OverStitch NXT Endoscopic Suturing System | June 29, 2023 |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | July 12, 2022 |
| K210266 | OverStitch Sx Endoscopic Suturing System | March 2, 2021 |
| K201808 | X-Tack Endoscopic HeliX Tacking System | December 15, 2020 |
| K191439 | OverStitch 2-0 Polypropylene Suture | August 29, 2019 |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | June 27, 2018 |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | November 15, 2017 |
| K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM | September 28, 2012 |
| K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM | October 28, 2011 |
| K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 | June 14, 2010 |
| K090583 | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 | June 26, 2009 |
| K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 | December 19, 2008 |
| K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM | August 18, 2008 |