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CapsoCam Plus

FDA UDI

Class II (US FDA UDI)

by CapsoVision, Inc.

Identity

Trade Name
CapsoCam Plus FDA UDI
Generic Name
Video capsule endoscopy system capsule FDA UDI
Device Name
Small Bowel Capsule Endoscope FDA UDI
Model / Reference
SV-3 FDA UDI
Description
Small Bowel Capsule Endoscope FDA UDI

Identifiers

Catalog Number
2795 FDA UDI
Primary DI / UDI-DI
00867770000209 FDA UDI
510(k) Number
K161773 FDA UDI
K183192 FDA UDI
K192662 FDA UDI
FDA Product Code
NEZ FDA UDI
GMDN Term
Video capsule endoscopy system capsule 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Video capsule endoscopy system capsule

CapsoCam Plus by CapsoVision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Video capsule endoscopy system capsule.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CapsoVision, Inc.

Sources (1)

  • FDA UDI b98684c8-c496-465b-86c9-e168d04410e2 36 fields · synced May 30, 2026