PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C— 510(k) K161445

Substantially Equivalent

Adapta Medical, Inc.

FDA 510(k) clearance K161445 for PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C, Substantially Equivalent on 2016-08-16. Applicant: Adapta Medical, Inc..

Clearance details

Applicant: Adapta Medical, Inc.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2016-05-25
Decision date: 2016-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.