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NaviCam Stomach System

FDA UDI

Class II (US FDA UDI)

by Anx Robotica Corp.

Identity

Trade Name
NaviCam Stomach System FDA UDI
Generic Name
Video capsule endoscopy monitoring kit FDA UDI
Device Name
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System. FDA UDI
Model / Reference
Locator AKS-1 FDA UDI
Description
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System. FDA UDI

Identifiers

Catalog Number
SB-US-2006 FDA UDI
Primary DI / UDI-DI
00850015518072 FDA UDI
510(k) Number
DEN190037 FDA UDI
FDA Product Code
QKZ FDA UDI
GMDN Term
Video capsule endoscopy monitoring kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1310 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Video capsule endoscopy monitoring kitVideo capsule endoscopy system capsule magnetic activator

NaviCam Stomach System by Anx Robotica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Video capsule endoscopy system capsule magnetic activator.

Cleared under the same submission

DEN190037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anx Robotica Corp.

Sources (1)

  • FDA UDI 685391fa-df2b-41dd-9bbc-25ca31c752f3 36 fields · synced Jun 1, 2026