The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Ivas 8 Gauge Bone Biopsy Kit.
| Device ID | K141673 |
| 510k Number | K141673 |
| Device Name: | IVAS 8 GAUGE BONE BIOPSY KIT |
| Classification | Instrument, Biopsy |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Brittney L Larsen |
| Correspondent | Brittney L Larsen STRYKER CORPORATION 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-23 |
| Decision Date | 2014-09-04 |
| Summary: | summary |