SOFT-TISSUE INSTRUMENT— 510(k) K841622

Substantially Equivalent

Plastafil, Inc.

FDA 510(k) clearance K841622 for SOFT-TISSUE INSTRUMENT, Substantially Equivalent on 1984-07-11. Applicant: Plastafil, Inc..

Clearance details

Applicant: Plastafil, Inc.
Product code: Code HWQ
Advisory panel: Orthopedic
Date received: 1984-04-19
Decision date: 1984-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWQ

product code HWQ

Injury: 137
Malfunction: 443
Total: 580

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.