OverStitch NXT Endoscopic Suturing System

FDA UDI

Class II (US FDA UDI)

by Apollo Endosurgery

Identity

Trade Name: OverStitch NXT Endoscopic Suturing System FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: Needle Driver and Anchor Exchange FDA UDI
Model / Reference: ESS-G02-NXT FDA UDI
Description: Needle Driver and Anchor Exchange FDA UDI

Identifiers

Catalog Number: ESS-G02-NXT FDA UDI
Primary DI / UDI-DI: 00811955020896 FDA UDI
FDA Product Code: OCW FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Suturing unit, single-use

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Apollo Endosurgery

Sources (1)

FDA UDI a728d802-6bb4-4dbe-8f3b-e6f425423719 35 fields · synced Jun 8, 2026