Submission Details
| 510(k) Number | K112598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 2011 |
| Decision Date | June 20, 2013 |
| Days to Decision | 652 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Special
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
Jun 2013
Decision
652d
Days
Class 2
Risk
About This 510(k) Submission
K112598 is an FDA 510(k) clearance for the AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND), a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by American Surgical Company, LLC (Lynn, US). The FDA issued a Cleared decision on June 20, 2013, 652 days after receiving the submission on September 7, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4700.
Device Classification
| Product Code | HBA — Neurosurgical Paddie |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4700 |
Manufacturer
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