510(k) · Cleared
ClearedProxis Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Mar 31, 2016 as substantially equivalent to K122649 (Boston Scientific Corp, 2012) after a 2-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Mar 31, 2016
- Review
- 2 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022135 (2002). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK022135 Ureteral Access Sheath Set (Uass)Boston Scientific Corp · 2002
- 1 generation backK122649 Navigator HD Ureteral Access Sheath SetBoston Scientific Corp · 2012
- This deviceK160861 Proxis Ureteral Access SheathC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK201815 Dornier MAGELLAN Ureteral Access SheathDornier Medtech America, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201815Dornier MAGELLAN Ureteral Access SheathDornier Medtech America, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022135 | Ureteral Access Sheath Set (Uass) | Boston Scientific Corp | 2002 | — |
| −1 | K122649 | Navigator HD Ureteral Access Sheath Set | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K160861 | Proxis Ureteral Access Sheath | C.R. Bard, Inc. | 2016 | — |
| +1 | K201815 | Dornier MAGELLAN Ureteral Access Sheath | Dornier Medtech America, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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 |
|---|---|---|---|
| * | K122649 | Navigator HD Ureteral Access Sheath SetSummary page 4…Device: Legally marketed device to which substantial equivalence is claimed • Boston Scientific Navigator TM HD Ureteral Access Sheath Set, K122649 Device Description Proxis™ Ureteral Access Sheath is a two component ureteral dilation system which contains 1) a sheath with a… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | 2020 | 0 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K201815 (Dornier Medtech America, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122649.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The Proxis™ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160861: Proxis Ureteral Access Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160861
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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