510(k) K843469— PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-

Substantially Equivalent

Zimmar Consulting , Ltd.

Clearance details

Applicant: Zimmar Consulting , Ltd.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1984-09-06
Decision date: 1984-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.