The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Urf-p2 Ureterorenofiberscope/choledochofiberscope.
| Device ID | K912120 |
| 510k Number | K912120 |
| Device Name: | URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170375078 | K912120 | 000 |
| 04953170058950 | K912120 | 000 |
| 04953170061516 | K912120 | 000 |
| 04953170063114 | K912120 | 000 |
| 04953170069048 | K912120 | 000 |
| 04953170286988 | K912120 | 000 |
| 04953170316593 | K912120 | 000 |
| 04953170340154 | K912120 | 000 |
| 04953170340307 | K912120 | 000 |
| 14953170375054 | K912120 | 000 |