K052802 is an FDA 510(k) clearance for the MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Manan Medical Products, Inc. (Wheeling, US). The FDA issued a Cleared decision on November 1, 2005, 29 days after receiving the submission on October 3, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K052802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2005 |
| Decision Date | November 01, 2005 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |