POD Packing Coil— 510(k) K170852

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K170852 for POD Packing Coil, Substantially Equivalent on 2017-07-19. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2017-03-22
Decision date: 2017-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.