OverStitch Endoscopic Suturing System

FDA UDI

Class I (US FDA UDI)

by Apollo Endosurgery

Identity

Trade Name: OverStitch 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-G02-160 FDA UDI
Description: Needle Driver and Anchor Exchange FDA UDI

Identifiers

Catalog Number: ESS-G02-160 FDA UDI
Primary DI / UDI-DI: 10811955020664 FDA UDI
FDA Product Code: HCF FDA UDI
OCW FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Suturing unit, single-use

OverStitch Endoscopic Suturing System by Apollo Endosurgery — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Apollo Endosurgery

Sources (1)

FDA UDI 7dc228d0-481f-4f8a-add2-0d1ab513f3ef 35 fields · synced Jun 8, 2026