K982735 is an FDA 510(k) clearance for the LIGHT SABER BONE BIOPSY NEEDLE. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Minrad, Inc. (Orchard Park, US). The FDA issued a Cleared decision on September 9, 1998, 35 days after receiving the submission on August 5, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K982735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1998 |
| Decision Date | September 09, 1998 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |