K180327 is an FDA 510(k) clearance for the Stryker iVAS 13g Bone Biopsy Kit, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on February 26, 2018, 20 days after receiving the submission on February 6, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K180327 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 2018 |
| Decision Date | February 26, 2018 |
| Days to Decision | 20 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 |