ARGYLE NEO-SERT— 510(k) K942564

Unknown

Sherwood Medical Co.

FDA 510(k) clearance K942564 for ARGYLE NEO-SERT, Unknown on 1994-08-25. Applicant: Sherwood Medical Co.. Device class: 2.

Clearance details

Applicant
Sherwood Medical Co.
Product code
Code FOS
Device class
Class 2
Regulation
21 CFR 880.5200
Advisory panel
General Hospital
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
St. Louis, MO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FOS

product code FOS
Death
12
Other
1
Total
13

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.