CapsoCam Plus (SV-3) Capsule Endoscope System— 510(k) K161773

Substantially Equivalent

CapsoVision, Inc.

FDA 510(k) clearance K161773 for CapsoCam Plus (SV-3) Capsule Endoscope System, Substantially Equivalent on 2016-10-21. Applicant: CapsoVision, Inc..

Clearance details

Applicant: CapsoVision, Inc.
Product code: Code NEZ
Advisory panel: Gastroenterology, Urology
Date received: 2016-06-28
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saratoga, CA, US

Download summary PDF View on FDA.gov ↗

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.