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American Surgical Company, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0287-2025Class IIAmericot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neuraSeptember 18, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K112598AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)June 20, 2013
K121822DELICOTSeptember 10, 2012