OverStitch Endoscopic Suturing System

FDA UDI

Class II (US FDA UDI)

by Apollo Endosurgery

Identity

Trade Name: OverStitch Endoscopic Suturing System FDA UDI
Generic Name: Polyolefin/fluoropolymer suture, monofilament FDA UDI
Device Name: Apollo 2-0 Polypropylene Suture to be utilized with the OverStitch Endoscopic Suturing System FDA UDI
Model / Reference: PLY-G02-020-APL FDA UDI
Description: Apollo 2-0 Polypropylene Suture to be utilized with the OverStitch Endoscopic Suturing System FDA UDI

Identifiers

Catalog Number: PLY-G02-020-APL FDA UDI
Primary DI / UDI-DI: 00811955020735 FDA UDI
FDA Product Code: GAW FDA UDI
GMDN Term: Polyolefin/fluoropolymer suture, monofilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Polyolefin/fluoropolymer suture, monofilament

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

Similar devices

Also classified as Polyolefin/fluoropolymer suture, monofilament.

SUTUMED — Unilene Sac · Class II
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DemeLENE — DemeTECH Corp · Class II
ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
DemeLENE — DemeTECH Corp · Class II
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
Premilene — B BRAUN SURGICAL SA · Class II
DEKNATEL — TELEFLEX INCORPORATED · Class II

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 944df80a-c131-4cb2-9572-24fd9b9b04c9 35 fields · synced Jun 8, 2026