K943863 is an FDA 510(k) clearance for the NEEDLE GUIDE. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Biopsys Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on December 29, 1994, 143 days after receiving the submission on August 8, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K943863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1994 |
| Decision Date | December 29, 1994 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |