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Balloon Applicator

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
Balloon Applicator FDA UDI
Generic Name
Surgical instrument assist arm system, manually-adjusted FDA UDI
Device Name
"MAJ-675 Balloon applicator for GF-UC30P" FDA UDI
Model / Reference
MAJ-675 FDA UDI
Description
"MAJ-675 Balloon applicator for GF-UC30P" FDA UDI

Identifiers

Primary DI / UDI-DI
04953170356001 FDA UDI
510(k) Number
K093395 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
NWB FDA UDI
ITX FDA UDI
ODG FDA UDI
GMDN Term
Surgical instrument assist arm system, manually-adjusted FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1550 FDA UDI
876.1500 FDA UDI
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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical instrument assist arm system, manually-adjusted

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

Similar devices

Also classified as Surgical instrument assist arm system, manually-adjusted.

Cleared under the same submission

K093395 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 5676d081-d173-44dd-b2d6-7bde2dc52cdc 35 fields · synced Jun 8, 2026