The following data is part of a premarket notification filed by Jbw7 Innovations, Llc with the FDA for Retroperc Flexible Ureteroscopy-guided Retrograde Nephrostomy Wire Puncture Set.
| Device ID | K160077 |
| 510k Number | K160077 |
| Device Name: | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set |
| Classification | Catheter, Nephrostomy |
| Applicant | JBW7 Innovations, LLC 22200 W. 11 Mile Road, # 4182 Southfield, MI 48037 |
| Contact | Jason B Wynberg |
| Correspondent | Jason B Wynberg JBW7 Innovations, LLC 22200 W. 11 Mile Road, # 4182 Southfield, MI 48037 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-14 |
| Decision Date | 2016-07-12 |
| Summary: | summary |