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Ultrasonic Probe

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
ULTRASONIC PROBE FDA UDI
Generic Name
Flexible endoscopic ultrasound imaging transducer FDA UDI
Device Name
"6890230 OLA UM-3R-3 ULTRASONIC PROBE 20M" FDA UDI
Model / Reference
UM-3R FDA UDI
Description
"6890230 OLA UM-3R-3 ULTRASONIC PROBE 20M" FDA UDI

Identifiers

Primary DI / UDI-DI
04953170063213 FDA UDI
510(k) Number
K001203 FDA UDI
K944610 FDA UDI
K982323 FDA UDI
K982610 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Flexible endoscopic ultrasound imaging transducer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 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 endoscopic ultrasound imaging transducer

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

Similar devices

Also classified as Flexible endoscopic ultrasound imaging transducer.

Cleared under the same submission

K001203 also covers:

K944610 also covers:

K982323 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 ab5c76d3-4fac-47b8-9f38-d02e8c672c67 35 fields · synced May 30, 2026