Apollo Endosurgery, Inc.
Austin, TX, US
Apollo Endosurgery, Inc. appears in FDA device records in Austin, TX. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Apollo Endosurgery, Inc. between 2008 and 2023. The busiest year on record is 2008, with 2. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | QTD | Substantially Equivalent | |
| K231553 | OverStitch NXT Endoscopic Suturing System | OCW | Substantially Equivalent | |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | QTD | Unknown | |
| K210266 | OverStitch Sx Endoscopic Suturing System | OCW | Substantially Equivalent | |
| K201808 | X-Tack Endoscopic HeliX Tacking System | PKL | Substantially Equivalent | |
| K191439 | OverStitch 2-0 Polypropylene Suture | OCW | Substantially Equivalent | |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | OCW | Substantially Equivalent | |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | OCW | Substantially Equivalent | |
| K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM | FED | Substantially Equivalent | |
| K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM | ODC | Substantially Equivalent | |
| K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 | FED | Unknown | |
| K090583 | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 | KGE | Substantially Equivalent | |
| K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 | KNS | Substantially Equivalent | |
| K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM | OCW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- ODCEndoscope Channel Accessory
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
- OCWEndoscopic Tissue Approximation Device
- KGEForceps, Biopsy, Electric
- PKLHemostatic Metal Clip For The Gi Tract
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2743-2018 | Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, depending on patient needs and progress. The Lap-Band access port is a low-profile cylindrical port attached to kink-resistant tubing . The port is implanted subcutaneously or in the rectus muscle and can be penetrated in its silicone septum by a non-coring needle to inject or remove saline into or from the band. The kink-resistant tubing connects the access port to the band. | Component of the Lap-Band system was missing from the package | Class II | Terminated | |
| Z-2732-2014 | LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions. | Product was distributed past its expiration date. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain