510(k) · Cleared
ClearedFlexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Dec 13, 2017 as substantially equivalent to K043418 (Cook Urological, Inc., 2005) and 1 other predicate after a 142-day review. Its family tree reaches back 3 generations to 1999. 2 later devices descend from it.
- Decided
- Dec 13, 2017
- Review
- 142 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K990775 (1999). 9 ancestors in all, the oldest K961904 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK990775 Ureteral Access Sheath SetApplied Medical Resources · 1999
- 2 generations backK993650 Ureteral Access Sheath Set - New ModelsApplied Medical Resources · 1999
- 1 generation backK043418 Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc. · 2005 · Recalled
- This deviceK172217 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release…Cook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK250132 Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK182403 Peel-Away IntroducerCook Incorporated · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990775 | Ureteral Access Sheath Set | Applied Medical Resources | 1999 | — |
| −2 | K993650 | Ureteral Access Sheath Set - New Models | Applied Medical Resources | 1999 | — |
| −1 | K043418 | Cook Pediatric Flexor Ureteral Access Shealth | Cook Urological, Inc. | 2005 | 1 |
| 0 (this device) | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral… | Cook Incorporated | 2017 | — |
| +1 | K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | 2025 | — |
| +1 | K182403 | Peel-Away Introducer | Cook Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 3 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K043418 | Cook Pediatric Flexor Ureteral Access ShealthSummary page 5…FED Device Class: II Classification Panel: Gastroenterology/Urology Predicate Devices: • The Cook® Pediatric Flexor Ureteral Access Sheath (K043418) is intended for use in establishing a conduit during endoscopic urological procedures facilitating the passage of endoscop… | 2005 |
| * | K140523 | RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CMSummary page 5…k® Pediatric Flexor Ureteral Access Sheath is intended for Pediatric Use in patients two years of age and older. • The Coloplast A/S Re-Trace Ureteral Access Sheath (K140523) is intended to be used to establish a continuous conduit during urological endoscopic procedures facilitating the passage… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K250132 (Zhejiang YiGao Medical Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K043418.
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. 2017, 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 Flexor® Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. Thirteen (13) cm length is intended for use in pediatric patients two (2) years of age and over.
The Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172217: Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release 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/K172217
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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