The following data is part of a premarket notification filed by Circon Video with the FDA for Apn-2 Usa Series Flexible Choledochoscope.
| Device ID | K012951 |
| 510k Number | K012951 |
| Device Name: | APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Wayne B Sterner |
| Correspondent | Wayne B Sterner CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2001-11-09 |