TU STOPCOCK— 510(k) K881805

Substantially Equivalent

Tulan Corp. C/O Richard Hamer Assoc.

FDA 510(k) clearance K881805 for TU STOPCOCK, Substantially Equivalent on 1988-10-04. Applicant: Tulan Corp. C/O Richard Hamer Assoc..

Clearance details

Applicant: Tulan Corp. C/O Richard Hamer Assoc.
Product code: Code FMG
Advisory panel: General Hospital
Date received: 1988-04-28
Decision date: 1988-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.