Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2023, with 2 FDA device recalls on record.
Top product codes for Apollo Endosurgery, Inc.
FDA recalls by Apollo Endosurgery, Inc.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Apollo Endosurgery, Inc.
- K232544 — Apollo ESG NXT System, Apollo REVISE NXT System
- K231553 — OverStitch NXT Endoscopic Suturing System
- DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
- K210266 — OverStitch Sx Endoscopic Suturing System
- K201808 — X-Tack Endoscopic HeliX Tacking System
- K171886 — OverStitch SX Endoscopic Suturing System (ESS)
- K122270 — OVERTUBE ENDOSCOPIC ACCESS SYSTEM
- K103155 — SUMO ACCESS AND TISSUE RESECTION SYSTEM
- K082102 — GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
- K090583 — ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
- K082114 — ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
- K081853 — OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.