The following data is part of a premarket notification filed by The Ruhof Corp. with the FDA for Scopevalet Disposable Biopsy Valve.
| Device ID | K122417 |
| 510k Number | K122417 |
| Device Name: | SCOPEVALET DISPOSABLE BIOPSY VALVE |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | THE RUHOF CORP. 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Kimberly Mccoy |
| Correspondent | Kimberly Mccoy THE RUHOF CORP. 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-08 |
| Decision Date | 2013-05-17 |
| Summary: | summary |