TRIP CIC CATHETER— 510(k) K920849

Substantially Equivalent

Tonometrics, Inc.

FDA 510(k) clearance K920849 for TRIP CIC CATHETER, Substantially Equivalent on 1995-03-17. Applicant: Tonometrics, Inc..

Clearance details

Applicant: Tonometrics, Inc.
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-25
Decision date: 1995-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

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.