K100520 is an FDA 510(k) clearance for the NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on March 17, 2010, 22 days after receiving the submission on February 23, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K100520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2010 |
| Decision Date | March 17, 2010 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIE — Needle, Fistula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |