The following data is part of a premarket notification filed by Suros Surgical Systems, Inc. with the FDA for Vacuum Assisted Core Biopsy Device.
| Device ID | K042290 |
| 510k Number | K042290 |
| Device Name: | VACUUM ASSISTED CORE BIOPSY DEVICE |
| Classification | Instrument, Biopsy |
| Applicant | SUROS SURGICAL SYSTEMS, INC. 9502 ANGOLA COURT SUITE 3 Indianapolis, IN 46268 |
| Contact | Joseph Mark |
| Correspondent | Joseph Mark SUROS SURGICAL SYSTEMS, INC. 9502 ANGOLA COURT SUITE 3 Indianapolis, IN 46268 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-24 |
| Decision Date | 2004-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420045503796 | K042290 | 000 |
| 15420045504875 | K042290 | 000 |
| 15420045504868 | K042290 | 000 |
| 15420045504851 | K042290 | 000 |
| 15420045504844 | K042290 | 000 |
| 15420045504837 | K042290 | 000 |
| 15420045504714 | K042290 | 000 |
| 15420045504615 | K042290 | 000 |
| 15420045504608 | K042290 | 000 |
| 15420045504592 | K042290 | 000 |
| 15420045504585 | K042290 | 000 |
| 15420045504578 | K042290 | 000 |
| 15420045504561 | K042290 | 000 |
| 15420045504295 | K042290 | 000 |
| 15420045504288 | K042290 | 000 |
| 15420045504110 | K042290 | 000 |
| 15420045504028 | K042290 | 000 |
| 15420045504882 | K042290 | 000 |
| 15420045504899 | K042290 | 000 |
| 15420045504905 | K042290 | 000 |
| 05420045503789 | K042290 | 000 |
| 05420045503734 | K042290 | 000 |
| 05420045503710 | K042290 | 000 |
| 05420045503208 | K042290 | 000 |
| 05420045503192 | K042290 | 000 |
| 05420045503178 | K042290 | 000 |
| 05420045503161 | K042290 | 000 |
| 05420045503154 | K042290 | 000 |
| 05420045503147 | K042290 | 000 |
| 05420045503130 | K042290 | 000 |
| 05420045503123 | K042290 | 000 |
| 05420045503116 | K042290 | 000 |
| 05420045503109 | K042290 | 000 |
| 15420045506855 | K042290 | 000 |
| 15420045506848 | K042290 | 000 |
| 15420045504912 | K042290 | 000 |
| 15420045503182 | K042290 | 000 |