510(k) · Cleared
ClearedPeel-Away Introducer
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 May 29, 2019 as substantially equivalent to K172217 (Cook Incorporated, 2017) and 1 other predicate after a 267-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- May 29, 2019
- Review
- 267 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K961904 (1996). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 3 generations backK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- 2 generations backK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · Recalled
- 1 generation backK123170 Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America · 2013
- This deviceK182403 Peel-Away IntroducerCook Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −3 | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| −2 | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | 2 |
| −1 | K123170 | Vari-Pass Variable Length Access Sheath | Olympus Surgical Technologies America | 2013 | — |
| 0 (this device) | K182403 | Peel-Away Introducer | Cook Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathSummary page 4…astroenterology/Urology Predicate Devices: The Cook Peel-Away® Introducer is substantially equivalent to the following devices: - Flexor® Ureteral Access Sheath (K172217, Cook Inc.) cleared on Dec. 13, 2017. - Vari-Pass™ Adjustable Length Access Sheath (K123170, Olympus Surgical Technologies… | 2017 |
| * | K123170 | Vari-Pass Variable Length Access SheathSummary page 4…valent to the following devices: - Flexor® Ureteral Access Sheath (K172217, Cook Inc.) cleared on Dec. 13, 2017. - Vari-Pass™ Adjustable Length Access Sheath (K123170, Olympus Surgical Technologies America) cleared on Feb. 4, 2013.… | 2013 |
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?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K172217.
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. 2019, 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 Peel-Away Introducer is intended to be used to establish a conduit during endoscopic urological procedures (e.g. nephrostomy, cystoscopy, ureteroscopy, etc.) 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/K182403 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182403: Peel-Away Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182403
Report an extraction error
Are you the manufacturer?
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