TENCKHOFF CATHETER— 510(k) K801818

Substantially Equivalent

Sil-Med Corp.

FDA 510(k) clearance K801818 for TENCKHOFF CATHETER, Substantially Equivalent on 1980-10-23. Applicant: Sil-Med Corp..

Clearance details

Applicant: Sil-Med Corp.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1980-07-31
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.