BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap— 510(k) K172575

Substantially Equivalent

Baronova, Inc.

FDA 510(k) clearance K172575 for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap, Substantially Equivalent on 2018-01-18. Applicant: Baronova, Inc..

Clearance details

Applicant: Baronova, Inc.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2017-08-28
Decision date: 2018-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.