K854713 is an FDA 510(k) clearance for the COTTON NEUROLOGICAL SPONGE. This device is classified as a Neurosurgical Paddie (Class II - Special Controls, product code HBA).
Submitted by American Silk Sutures, Inc. (Ledyard, US). The FDA issued a Cleared decision on March 20, 1986, 118 days after receiving the submission on November 22, 1985.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4700.
| 510(k) Number | K854713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1985 |
| Decision Date | March 20, 1986 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HBA — Neurosurgical Paddie |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4700 |