THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT— 510(k) K974038

Substantially Equivalent

A & A Medical, Inc.

FDA 510(k) clearance K974038 for THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT, Substantially Equivalent on 1998-05-11. Applicant: A & A Medical, Inc..

Clearance details

Applicant
A & A Medical, Inc.
Product code
Code JCX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alpharetta, GA, 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.