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Oes Cystonephrofiberscope

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
OES CYSTONEPHROFIBERSCOPE FDA UDI
Generic Name
Flexible fibreoptic cystonephroscope FDA UDI
Device Name
OES CYSTONEPHROFIBERSCOPE FDA UDI
Model / Reference
OLYMPUS CYF-5 FDA UDI
Description
OES CYSTONEPHROFIBERSCOPE FDA UDI

Identifiers

Primary DI / UDI-DI
04953170411144 FDA UDI
510(k) Number
K221690 FDA UDI
FDA Product Code
FAJ FDA UDI
GMDN Term
Flexible fibreoptic cystonephroscope 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible fibreoptic cystonephroscope

Oes Cystonephrofiberscope by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic cystonephroscope.

Cleared under the same submission

K221690 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI dadba846-4c6d-4e37-be63-f3768b54a7b3 35 fields · synced Jun 1, 2026