ENDO STRATUS CO2 Insufflator

FDA UDI

Class II (US FDA UDI)

by Medivators Inc.

Identity

Trade Name: ENDO STRATUS CO2 Insufflator FDA UDI
Generic Name: Gastrointestinal endoscopic insufflator FDA UDI
Model / Reference: EGA-501 FDA UDI

Identifiers

Primary DI / UDI-DI: 00677964063671 FDA UDI
510(k) Number: K113310 FDA UDI
FDA Product Code: FCX FDA UDI
GMDN Term: Gastrointestinal endoscopic insufflator 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

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrointestinal endoscopic insufflator

ENDO STRATUS CO2 Insufflator by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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IRRIGATOR/INSUFFLATOR — PENTAX of America, Inc. · Class II
Protocol Touch Colon Insufflator — Bracco Diagnostics Inc. · Class II

Cleared under the same submission

K113310 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 a3c2e028-dc7d-411f-897a-e91437fcad48 34 fields · synced Jun 1, 2026