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Apollo ESG NXT System

FDA UDI

Class II (US FDA UDI)

by Apollo Endosurgery

Identity

Trade Name
Apollo ESG NXT System FDA UDI
Generic Name
Suturing unit, single-use FDA UDI
Device Name
Single Channel Endobariatric System FDA UDI
Model / Reference
APL-ESG-NXT FDA UDI
Description
Single Channel Endobariatric System FDA UDI

Identifiers

Catalog Number
APL-ESG-NXT FDA UDI
Primary DI / UDI-DI
00811955020933 FDA UDI
FDA Product Code
QTD FDA UDI
GMDN Term
Suturing unit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5983 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Suturing unit, single-use

Apollo ESG NXT System by Apollo Endosurgery — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suturing unit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apollo Endosurgery

Sources (1)

  • FDA UDI 1ab4b0d8-5c57-4ffa-a247-b3efe991023a 35 fields · synced May 30, 2026