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Endocapsule Software 10 Upgrade Package

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE FDA UDI
Generic Name
Video capsule endoscopy system application software FDA UDI
Model / Reference
MAJ-2190 FDA UDI

Identifiers

Catalog Number
N5400540 FDA UDI
Primary DI / UDI-DI
04953170373848 FDA UDI
510(k) Number
K183053 FDA UDI
FDA Product Code
NEZ FDA UDI
GMDN Term
Video capsule endoscopy system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1300 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Video capsule endoscopy system application software

Endocapsule Software 10 Upgrade Package by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Video capsule endoscopy system application software.

Cleared under the same submission

K183053 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 4bbd3d1e-3d77-4bab-ae8d-72994a956576 35 fields · synced May 30, 2026