STOPCOCK— 510(k) K913560

Substantially Equivalent

Graham Medical Products

FDA 510(k) clearance K913560 for STOPCOCK, Substantially Equivalent on 1991-12-31. Applicant: Graham Medical Products.

Clearance details

Applicant: Graham Medical Products
Product code: Code FMG
Advisory panel: General Hospital
Date received: 1991-08-09
Decision date: 1991-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holyoke, MA, 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.