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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
APOLLO ESG Sx™ System	APL-ESG-SX1	FDA UDI	Class II	Active
OverStitch Endoscopic Suturing System	PLY-G02-020-APL	FDA UDI	Class II	Active
LAP-BAND AP Adjustable Gastric Banding System	B-2245	FDA UDI	Class III	Unknown
RapidPort EZ Tubing Kit	A-20331	FDA UDI	Class III	Unknown
LAP-BAND AP Adjustable Gastric Banding System	B-2240	FDA UDI	Class III	Unknown
OverStitch NXT Endoscopic Suturing System	ESS-ESG-NXT	FDA UDI	Class II	Active
LAP-BAND System Access Port I Kit	B-2104	FDA UDI	Class III	Unknown
OverStitch NXT Endoscopic Suturing System	ESS-G02-NXT	FDA UDI	Class II	Active
LAP-BAND Calibration Tube	A-2017	FDA UDI	Class III	Unknown
Lap-Band	C-2365	FDA UDI	Class III	Unknown
Lap-Band	B-20302	FDA UDI	Class III	Unknown
OverStitch Endoscopic Suturing System Sx	ESS-G02-Sx1	FDA UDI	Class I	Active
RapidPort EZ	C-20390	FDA UDI	Class III	Unknown
APOLLO Revise™ System	APL-REV-160	FDA UDI	Class II	Active
Apollo ESG NXT System	APL-ESG-NXT	FDA UDI	Class II	Active
X-Tack Endoscopic HeliX Tacking System	XTACK-235-H	FDA UDI	Class II	Active
RapidPort EZ	C-2306	FDA UDI	Class III	Unknown
RapidPort EZ	C-2304	FDA UDI	Class III	Unknown
The LAP-BAND Adjustable Gastric Banding System with the Access Port II	B-2215	FDA UDI	Class III	Unknown
OverStitch Endoscopic Suturing System	ESS-G02-160	FDA UDI	Class I	Active
Access Port RapidPort EZ Kit	B-2306	FDA UDI	Class III	Unknown
LAP-BAND System Access Port I Kit	B-2101	FDA UDI	Class III	Unknown
X-Tack Endoscopic HeliX Tacking System	CNH-C01-213-L	FDA UDI	Class II	Active
OverTube Endoscopic Access System	OVT-027-160	FDA UDI	Class II	Active
Lap-Band	B-2017	FDA UDI	Class III	Unknown
LAP-BAND System Access Port II Kit	B-2106	FDA UDI	Class III	Unknown
LAP-BAND Tubing Kit	A-20401	FDA UDI	Class III	Unknown
LAP-BAND AP Adjustable Gastric Banding System	B-2260	FDA UDI	Class III	Unknown
LAP-BAND System Access Port II Kit	B-2103	FDA UDI	Class III	Unknown
The LAP-BAND Adjustable Gastric Banding System	B-2250	FDA UDI	Class III	Unknown
LAP-BAND AP Adjustable Gastric Banding System	B-2265	FDA UDI	Class III	Unknown
APOLLO ESG™ System	APL-ESG-160	FDA UDI	Class II	Active
NXT Tissue Helix Pro	NXT-THXP-130	FDA UDI	Class II	Active
Lap-Band	B-20401	FDA UDI	Class III	Unknown
RapidPort EZ Port Applier Tool	B-20390	FDA UDI	Class III	Unknown
OverStitch Endoscopic Suturing System	CNH-G01-000	FDA UDI	Class I	Active
LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ	B-2360	FDA UDI	Class III	Unknown
OverTube Endoscopic Access System	OVT-S27-160	FDA UDI	Class II	Active
ORBERA Intragastric Balloon System	B-4800	FDA UDI	Class III	Active
Apollo Revise NXT System	APL-REV-NXT	FDA UDI	Class II	Active
Lap-Band	B-20301	FDA UDI	Class III	Unknown
LAP-BAND System Access Port II Kit	B-2105	FDA UDI	Class III	Unknown
APOLLO REVISE™ Sx System	APL-REV-Sx1	FDA UDI	Class II	Active
OverStitch Endoscopic Suturing System	THX-165-028	FDA UDI	Class I	Active
Access Port RapidPort EZ Kit	B-2304	FDA UDI	Class III	Unknown
LAP-BAND System Access Port I Kit	B-2107	FDA UDI	Class III	Unknown
Gastric Balloon Suction Catheter	B-2020	FDA UDI	Class II	Active
X-Tack Endoscopic HeliX Tacking System	XTACK-160-H	FDA UDI	Class II	Active
The LAP-BAND Adjustable Gastric Banding System with the Access Port II	B-2225	FDA UDI	Class III	Unknown
The LAP-BAND Adjustable Gastric Banding System with the Access Port II	B-2255	FDA UDI	Class III	Unknown

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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.