PENROSE DRAIN MODELS 6001 - 6007— 510(k) K960099

Substantially Equivalent

Sil-Med Corp.

FDA 510(k) clearance K960099 for PENROSE DRAIN MODELS 6001 - 6007, Substantially Equivalent on 1996-03-11. Applicant: Sil-Med Corp..

Clearance details

Applicant: Sil-Med Corp.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1996-01-11
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.