510(k) K242643— CapsoCam Plus (SV-3) Capsule Endoscopy System

Substantially Equivalent

CapsoVision, Inc.

Clearance details

Applicant: CapsoVision, Inc.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-03
Decision date: 2024-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saratoga, CA, US

Adverse events under product code NEZ

product code NEZ

Death: 11
Injury: 218
Total: 229

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.