American Surgical Company, LLC

FDA Regulatory Profile

American Surgical Company, LLC appears in FDA public data with 1 recall, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0287-2025, Class II) was initiated on September 18, 2024. Its most recent 510(k) clearance was granted on June 20, 2013.

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