Apollo Endosurgery
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Apollo Endosurgery is a medical device manufacturer, with 70 devices listed in FDA GUDID and FDA 510(k) (FDA Class III, II and I) and 2 FDA recalls as of 14 Nov 2026.
- Devices
- 70
- FDA recalls
- 2
Registry facts
- Registries
- FDA GUDID 56
- FDA 510(k) 14
- Device classes
- FDA Class III 35
- FDA Class II 31
- FDA Class I 4
- FDA recalls
At a glance
Market reach
- United States
- FDA recalls
What Apollo Endosurgery makes
The company manufactures endoscopic suturing systems designed for tissue approximation and closure, including single-use units with detachable needles and cartridges for gastrointestinal procedures. It also produces short-term endoscopic clips for securing tissue or controlling bleeding in the gastrointestinal tract, as well as single-use overtubes to facilitate endoscopic access. Additionally, the portfolio includes polyolefin/fluoropolymer monofilament sutures for endoscopic applications, gastric calibration tubes for dilation, and appetite-suppression gastric balloons for weight management interventions.
The company’s devices are regulated under the US FDA, with products classified as Class I, Class II, and Class III depending on risk level. These devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, ensuring traceability and compliance with US medical device regulations.
Catalogue
Search and filter all 70 devicesShowing 1-50 of 70
FDA recalls
FDA recall records list 2 recalls initiated by Apollo Endosurgery, the earliest on 2014-08-15 and the most recent on 2017-11-22. By recorded status: 2 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 22 Nov 2017 Z-2743-2018 Class II Terminated Component of the Lap-Band system was missing from the package
Full distribution text
- 22 Nov 2017 Z-2743-2018 Class II Terminated Component of the Lap-Band system was missing from the package
2014
- 15 Aug 2014 Z-2732-2014 Class II Terminated Product was distributed past its expiration date.
Frequently asked questions
How many devices does Apollo Endosurgery have in the registry?
The registry currently lists 70 devices for Apollo Endosurgery. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apollo Endosurgery's devices?
Among its 50 most recently registered devices, Apollo Endosurgery has devices listed in FDA GUDID (50 devices).
What risk classes do Apollo Endosurgery's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Apollo Endosurgery's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Apollo Endosurgery?
FDA recall records list 2 recalls initiated by Apollo Endosurgery, the most recent initiated on 22 Nov 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Apollo Endosurgery in the registry?
The most recently registered devices listed for Apollo Endosurgery include APOLLO ESG Sx™ System APL-ESG-SX1, OverStitch Endoscopic Suturing System PLY-G02-020-APL, LAP-BAND AP Adjustable Gastric Banding System B-2245 and RapidPort EZ Tubing Kit A-20331.