The following data is part of a premarket notification filed by Circon Video with the FDA for Micro-6-series (mr-6, Mr-6l) Ureteroscopes, Mro-6 Series (mr-633, Mr-642) Ureteroscopes, Mro-7 Series (mro-733) Ureteros.
| Device ID | K011849 |
| 510k Number | K011849 |
| Device Name: | MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS |
| 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 | 2001-06-13 |
| Decision Date | 2001-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925009295 | K011849 | 000 |
| 00821925007840 | K011849 | 000 |
| 00821925006676 | K011849 | 000 |
| 00821925001541 | K011849 | 000 |