Endogator

FDA UDI

Class II (US FDA UDI)

by Medivators Inc.

Identity

Trade Name: ENDOGATOR FDA UDI
Generic Name: Surgical irrigation tubing set, single-use FDA UDI
Device Name: ENDOGATOR Backflow Valve FDA UDI
Model / Reference: 100126 FDA UDI
Description: ENDOGATOR Backflow Valve FDA UDI

Identifiers

Catalog Number: 100126 FDA UDI
Primary DI / UDI-DI: 00677964058455 FDA UDI
510(k) Number: K033695 FDA UDI
K220395 FDA UDI
FDA Product Code: OCX FDA UDI
FEQ FDA UDI
GMDN Term: Surgical irrigation tubing set, 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

FDA UDI

Category: Surgical irrigation tubing set, single-use

Endogator by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation tubing set, single-use.

SuperFlow Tubing Set — ARMM INC. · Class II
Irrigation Set — B. BRAUN MEDICAL INC. · Class II
IPC™ Visao® — MEDTRONIC XOMED, INC. · Class II
Arthrex® — Arthrex, Inc. · Class I
CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
Endo-Flo — Davol Inc. · Class II
AESCULAP — AESCULAP, INC. · Class II

Cleared under the same submission

K033695 also covers:

K220395 also covers:

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: Medivators Inc.

Sources (1)

FDA UDI c1a24357-ae3e-4413-bd4b-18e3241e9006 36 fields · synced May 30, 2026