Clearance Summary
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) received FDA 510(k) clearance under submission number K112598, sponsored by American Surgical Company, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-06-20.
- Submission: K112598
- Applicant / Sponsor: American Surgical Company, LLC
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4700
- Decision date: 2013-06-20
Classification & Regulation
This clearance is catalogued under FDA product code HBA and 21 CFR 882.4700, within the Neurology review panel as a Class II device.