The following data is part of a premarket notification filed by Circon Video with the FDA for Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models Mr-9, Mr-9l,.
| Device ID | K012758 |
| 510k Number | K012758 |
| Device Name: | URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Wayne Sterner |
| Correspondent | Wayne 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 | 2001-08-17 |
| Decision Date | 2002-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925008021 | K012758 | 000 |
| 00821925008038 | K012758 | 000 |
| 00821925001220 | K012758 | 000 |
| 00821925027305 | K012758 | 000 |
| 00821925010970 | K012758 | 000 |