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Balloon3

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
BALLOON3 FDA UDI
Generic Name
Ultrasound endoscope balloon, Hevea-latex FDA UDI
Model / Reference
MAJ-233 FDA UDI

Identifiers

Primary DI / UDI-DI
04953170058783 FDA UDI
510(k) Number
K051541 FDA UDI
FDA Product Code
FDF FDA UDI
ITX FDA UDI
GMDN Term
Ultrasound endoscope balloon, Hevea-latex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ultrasound endoscope balloon, Hevea-latex

Balloon3 by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound endoscope balloon, Hevea-latex.

Cleared under the same submission

K051541 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 d7fc2c8c-edfd-437b-aeaf-376e87ef7cb1 34 fields · synced Jun 1, 2026