PERCUTANEOUS DRAINING CATHETER— 510(k) K811378

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K811378 for PERCUTANEOUS DRAINING CATHETER, Substantially Equivalent on 1981-06-02. Applicant: Medi-Tech, Inc..

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code GBW
Advisory panel: General, Plastic Surgery
Date received: 1981-05-15
Decision date: 1981-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBW

product code GBW

Death: 6
Total: 6

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.