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NaviCam Capsule Endoscope System

FDA UDI

Class II (US FDA UDI)

by Anx Robotica Corp.

Identity

Trade Name
NaviCam Capsule Endoscope System FDA UDI
Generic Name
Video capsule endoscopy system capsule magnetic manipulation unit FDA UDI
Device Name
Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator. FDA UDI
Model / Reference
Controller/NaviEC-1000 FDA UDI
Description
Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator. FDA UDI

Identifiers

Catalog Number
MC-US-1001 FDA UDI
Primary DI / UDI-DI
00850015518201 FDA UDI
510(k) Number
DEN190037 FDA UDI
FDA Product Code
QKZ FDA UDI
GMDN Term
Video capsule endoscopy system capsule magnetic manipulation unit 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
MRI Safety
MR Unsafe FDA UDI

Category: Video capsule endoscopy system capsule magnetic manipulation unit

NaviCam Capsule Endoscope 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 manipulation unit.

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 04736d55-086b-4b78-9ba5-b35e164aefc6 35 fields · synced Jun 1, 2026