510(k) · Cleared
ClearedRetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jbw7 Innovations, LLC · LJE Catheter, Nephrostomy
Cleared on Jul 12, 2016 as substantially equivalent to K833762 (Vpi, 1984) after a 180-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jul 12, 2016
- Review
- 180 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833762 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK833762 Percutaneous Retrograde NephrostomyVpi · 1984 · Recalled
- This deviceK160077 RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire…Jbw7 Innovations, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833762 | Percutaneous Retrograde Nephrostomy | Vpi | 1984 | 1 |
| 0 (this device) | K160077 | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set | Jbw7 Innovations, LLC | 2016 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LJE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LJE device
- #1 K250448 Disposable Percutaneous Nephrostomy Dilatation…score 9.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K833762 | Percutaneous Retrograde NephrostomySummary page 4…ation Panel: None Legally Marketed Predicate Device: Lawson Retrograde Nephrostomy Wire Puncture Set, Cook Medical, K833762 Device Description The RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K833762.
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LJE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJE
254in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJE
59in 2025
MAUDE reports naming product code LJE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 5 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 26 |
| 2017 | 1 | — | 0 | 60 |
| 2018 | 3 | 107 | 0 | 69 |
| 2019 | 4 | 254 | 1 | 78 |
| 2020 | 2 | — | 2 | 50 |
| 2021 | 0 | — | 1 | 38 |
| 2022 | 1 | — | 0 | 42 |
| 2023 | 1 | — | 0 | 131 |
| 2024 | 0 | — | 0 | 47 |
| 2025 | 1 | — | 1 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160077: RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160077
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026