Endoscope 5.5 MM Sterile, Reusable

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name: Endoscope 5.5 MM Sterile, Reusable FDA UDI
Generic Name: Rigid optical reconstructive surgery endoscope FDA UDI
Model / Reference: MCENDO550 FDA UDI

Identifiers

Primary DI / UDI-DI: 00699753018952 FDA UDI
510(k) Number: K160206 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Rigid optical reconstructive surgery endoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid optical reconstructive surgery endoscope

Endoscope 5.5 MM Sterile, Reusable by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Rigid optical reconstructive surgery endoscope.

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Cleared under the same submission

K160206 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: Terumo Cardiovascular Systems Corporation

Sources (1)

FDA UDI 0efda458-f075-4617-aa38-6b7fbc2d636e 33 fields · synced Jun 9, 2026