The following data is part of a premarket notification filed by Biopsys Medical, Inc. with the FDA for Needle Guide.
| Device ID | K943863 |
| 510k Number | K943863 |
| Device Name: | NEEDLE GUIDE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BIOPSYS MEDICAL, INC. 27130 A PASEO ESPADA, SUITE 1424 San Juan Capistrano, CA 92675 |
| Contact | Mark A Cole |
| Correspondent | Mark A Cole BIOPSYS MEDICAL, INC. 27130 A PASEO ESPADA, SUITE 1424 San Juan Capistrano, CA 92675 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1994-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841911101215 | K943863 | 000 |
| 10841911100789 | K943863 | 000 |
| 10841911100796 | K943863 | 000 |
| 10841911100802 | K943863 | 000 |
| 10841911101120 | K943863 | 000 |
| 10841911101137 | K943863 | 000 |
| 10841911101144 | K943863 | 000 |
| 10841911101151 | K943863 | 000 |
| 10841911101168 | K943863 | 000 |
| 10841911101175 | K943863 | 000 |
| 10841911101182 | K943863 | 000 |
| 10841911101199 | K943863 | 000 |
| 00841911101758 | K943863 | 000 |
| 10841911100772 | K943863 | 000 |