K063697 is an FDA 510(k) clearance for the SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on February 14, 2007, 63 days after receiving the submission on December 13, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K063697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2006 |
| Decision Date | February 14, 2007 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |