Otv-S500 Upgrade Pack Strobe

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: OTV-S500 UPGRADE PACK STROBE FDA UDI
Generic Name: Software upgrade/unlocking key FDA UDI
Model / Reference: MAJ-2547 FDA UDI

Identifiers

Catalog Number: N6216940 FDA UDI
Primary DI / UDI-DI: 04953170458170 FDA UDI
510(k) Number: K243380 FDA UDI
FDA Product Code: EOB FDA UDI
EOQ FDA UDI
NWB FDA UDI
EQL FDA UDI
NTN FDA UDI
HET FDA UDI
GMDN Term: Software upgrade/unlocking key FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4760 FDA UDI
874.4680 FDA UDI
876.1500 FDA UDI
874.4750 FDA UDI
884.1720 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: Software upgrade/unlocking key

Otv-S500 Upgrade Pack Strobe by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K243380 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 II	Pending data

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Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI 02a93446-9739-4058-bb41-66b43cf29607 35 fields · synced May 31, 2026