# K160077: RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set

- Pathway: 510(k) (Traditional)
- Applicant: Jbw7 Innovations, LLC
- Decided: Jul 12, 2016 after 180 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K833762 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833762: Percutaneous Retrograde Nephrostomy, Vpi (1984) Summary page 4.

## Indications for use
Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. This set and suggested procedure are particularly well-suited for gaining percutaneous access to an unobstructed, non-dilated collecting system when pursuing a planned course of endourological intervention. Fluoroscopic control is necessary throughout this procedure. Intended for one-time use.

Source page: https://510kreport.com/device/K160077
Methodology: https://510kreport.com/methodology