Submission Details
| 510(k) Number | K140369 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 2014 |
| Decision Date | September 26, 2014 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
Cleared
Traditional
MEDLINE NEURO SPONGE
Sep 2014
Decision
224d
Days
Class 2
Risk
About This 510(k) Submission
K140369 is an FDA 510(k) clearance for the MEDLINE NEURO SPONGE, a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on September 26, 2014, 224 days after receiving the submission on February 14, 2014. 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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