K153243 is an FDA 510(k) clearance for the Fehling-Punches. This device is classified as a Rongeur, Manual (Class II - Special Controls, product code HAE).
Submitted by Fehling Instruments GmbH & Co. KG (Karlstein, DE). The FDA issued a Cleared decision on August 4, 2016, 269 days after receiving the submission on November 9, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4840.
| 510(k) Number | K153243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2015 |
| Decision Date | August 04, 2016 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAE — Rongeur, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4840 |