Ultrasonic Generator

FDA UDI

Class U (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: Ultrasonic Generator FDA UDI
Generic Name: Ultrasonic surgical system generator FDA UDI
Device Name: "USG-400 Ultrasonic Generator" FDA UDI
Model / Reference: USG-400 FDA UDI
Description: "USG-400 Ultrasonic Generator" FDA UDI

Identifiers

Primary DI / UDI-DI: 04953170306747 FDA UDI
510(k) Number: K172691 FDA UDI
FDA Product Code: LFL FDA UDI
KNS FDA UDI
GEI FDA UDI
GMDN Term: Ultrasonic surgical system generator FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 876.4300 FDA UDI
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

Category: Ultrasonic surgical system generator

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

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Cleared under the same submission

K172691 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 U	Pending data

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Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI 23a2ac15-7a4f-4f7c-8994-59b5df7125f6 35 fields · synced Jun 8, 2026