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CapsoCam Plus (SV-3) Capsule Endoscope System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161773

by CapsoVision, Inc.

Identifiers

510(k) Number
K161773 FDA 510(k)
FDA Product Code
NEZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1300 FDA 510(k)
Regulation Number
876.1300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CapsoCam Plus (SV-3) Capsule Endoscope System is a wireless, ingestible imaging device classified as a gastrointestinal capsule endoscope. It captures high-resolution images of the small intestine and other gastrointestinal regions as it passes naturally through the digestive tract, enabling non-invasive visualization of the mucosal lining for diagnostic purposes.

This system is designed for single-use and requires no external power source beyond the ingestible capsule itself. It is intended for use in clinical settings such as gastroenterology and urology, with FDA 510(k) clearance and compliance with the Medical Device Regulation (MDR). The system includes multiple capsule variants (FEI numbers listed) and is supplied with proprietary imaging software for data acquisition and analysis, adhering to Class II regulatory standards under 876.1300.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
CapsoVision, Inc.

Sources (2)

  • FDA 510(k) K161773 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026