The following data is part of a premarket notification filed by Innovative Endoscopy Components, Llc. with the FDA for Rudolf Innoview Autoclavable Semi-rigid Uretero-renoscope.
| Device ID | K062707 |
| 510k Number | K062707 |
| Device Name: | RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. 731-733 SHOTGUN RD. Ft. Lauderdale, FL 33326 |
| Contact | Gerald Goigitzer |
| Correspondent | Gerald Goigitzer INNOVATIVE ENDOSCOPY COMPONENTS, LLC. 731-733 SHOTGUN RD. Ft. Lauderdale, FL 33326 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2006-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B192300646000 | K062707 | 000 |
| B192300514000 | K062707 | 000 |
| B192300068000 | K062707 | 000 |