MODEL 2300 GENERAL PURPOSE SUCTION PUMP— 510(k) K941527

Substantially Equivalent

Product & Educational Services

FDA 510(k) clearance K941527 for MODEL 2300 GENERAL PURPOSE SUCTION PUMP, Substantially Equivalent on 1994-05-18. Applicant: Product & Educational Services.

Clearance details

Applicant
Product & Educational Services
Product code
Code JCX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dolestown, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JCX

product code JCX
Death
11
Malfunction
838
Other
1
Total
850

Source: openFDA MAUDE database, through . 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.