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Apollo Endosurgery

Last updated May 23, 2026

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. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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Catalogue (70)

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Device	Model / Reference	Registries	Class	Status
The LAP-BAND Adjustable Gastric Banding System	B-2220	FDA UDI	Class III	Unknown
Lap-Band	C-2360	FDA UDI	Class III	Unknown
LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ	B-2365	FDA UDI	Class III	Unknown
The LAP-BAND Adjustable Gastric Banding System	B-2210	FDA UDI	Class III	Unknown
LAP-BAND System Adjustment Kit	B-20310	FDA UDI	Class III	Unknown
Apollo 2-0 Polypropylene Endobariatric Suture	PLY-G02-020-BAR	FDA UDI	Class II	Active
OverStitch SX Endoscopic Suturing System (ESS)	K171886	FDA 510(k)	Class II	Active
Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00	K082114	FDA 510(k)	Class II	Active
Endoscopic Monopolar Scissors, Models Ems-235, Ems-165	K090583	FDA 510(k)	Class II	Active
X-Tack Endoscopic HeliX Tacking System	K201808	FDA 510(k)	Class II	Active
Overtube Endoscopic Access System	K122270	FDA 510(k)	Class II	Active
Apollo ESG NXT System, Apollo REVISE NXT System	K232544	FDA 510(k)	Class II	Active
OverStitch NXT Endoscopic Suturing System	K231553	FDA 510(k)	Class II	Active
Sumo Access And Tissue Resection System	K103155	FDA 510(k)	Class II	Active
OverStitch 2-0 Polypropylene Suture	K191439	FDA 510(k)	Class II	Active
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System	DEN210045	FDA 510(k)	Class II	Active
Gastric Port, Models: Gap-0016-00, Gap-0018-00, Gap-0020-00	K082102	FDA 510(k)	Class II	Active
Overstitch Endoscopic Suture System	K081853	FDA 510(k)	Class II	Active
OverStitch Sx Endoscopic Suturing System	K210266	FDA 510(k)	Class II	Active
OverStitch Endoscopic Suturing System and Accessories	K181141	FDA 510(k)	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Apollo Endosurgery has two FDA recall records, both initiated as voluntary actions in 2014 and 2017. The first, initiated on 2014-08-15, involved missing components in the Lap-Band system packaging, while the second, initiated on 2017-11-22, concerned distribution of products past their expiration dates. Both recalls have been terminated according to the records.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 22, 2017	Z-2743-2018	—	terminated	Component of the Lap-Band system was missing from the package
Aug 15, 2014	Z-2732-2014	—	terminated	Product was distributed past its expiration date.