Submission Details
| 510(k) Number | K121822 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 21, 2012 |
| Decision Date | September 10, 2012 |
| Days to Decision | 81 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Special
DELICOT
Sep 2012
Decision
81d
Days
Class 2
Risk
About This 510(k) Submission
K121822 is an FDA 510(k) clearance for the DELICOT, 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 September 10, 2012, 81 days after receiving the submission on June 21, 2012. 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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