510(k) Report

510(k) · Cleared

Cleared

Wilson-Cook Cystotome

K022595510(k) TraditionalCleared Oct 17, 200273-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wilson-Cook Medical, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Oct 17, 2002 as substantially equivalent to K972674 (Wilson-Cook Medical, Inc., 1997) and 2 other predicates after a 73-day review. Its family tree reaches back 2 generations to 1997. 29 later devices descend from it.

Decided
Oct 17, 2002
Review
73 days
Class
Class II
Product code
KNS
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K970053 (1997). 4 ancestors in all. 29 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 2 other ancestors2010: 1 descendant cleared2023: 1 descendant cleared2009: 1 descendant cleared2022: 2 descendants cleared2015: 4 descendants cleared2026: 2 descendants cleared2017: 4 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2019: 3 descendants cleared2014: 2 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2024: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant clearedK970053 · Ultratomerx · Boston Scientific Corp · 1997K013153 · Autotome RX Model # 4515, 4516 · Boston Scientific Corp · 2001 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 7 descendants4 generations forward: 7 descendants5 generations forward: 4 descendants K013153 · Autotome RX Model # 4515, 4516 · Boston Scientific Corp · 2001 · recalledK970053 · Ultratomerx · Boston Scientific Corp · 19970+5
  1. Root · 2 generations backK970053 UltratomerxBoston Scientific Corp · 1997
  2. 1 generation backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
  3. This deviceK022595 Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002
  4. Descendant · cites it directly · 16 of its ownK092359 Echo Tip Ultra High Definition Ultrasound Access Needle, Model…Cook Ireland, Ltd. · 2009 · Recalled
  5. Descendant · 2 generations on · 11 of its ownK123676 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013
  6. Descendant · 3 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
  7. Descendant · 4 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
  8. Descendant · cites it directly · 8 of its ownK150692 AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12013: 12014: 22015: 42016: 12017: 42018: 12019: 32020: 22021: 22022: 22023: 12024: 12025: 12026: 2
2009high 4 (2015) · low 0 (2011)2026

Most influential descendants

Showing 5 of 29 · See all
  • K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd. · 2009 · cites it directly16descendants
  • K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013 · 2 generations on11descendants
  • K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 3 generations on10descendants
  • K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 4 generations on9descendants
  • K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015 · cites it directly8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K970053UltratomerxBoston Scientific Corp1997—
−1K013153Autotome RX Model # 4515, 4516Boston Scientific Corp200132
0 (this device)K022595Wilson-Cook CystotomeWilson-Cook Medical, Inc.2002—
+1K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd.20091
+2K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies2013—
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes…Daniel & Daniel Consulting2014—
+4K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies2014—
+1K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201310
201420
201540
201610
201740
201810
201930
202020
202120
202220
202310
202410
202510
202620
FIG. 1 — Lineage of K022595, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KNS? 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 KNS device

  1. #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K972674Wilson-Cook Needle Knife Papillotome
Summary page 1
…21 CFR 876.4300 (78KNS); Class I1 Predicate Devices: The Wilson-Cook Cystotome is comparable to predicate devices including the Wilson- Cook Needle Knife Papillotome (K972674); the Boston Scientific AutotomeTM RX (KO13 153); and the Boston Scientific Microvasive Gold Probe (K970278). Device Description…
Wilson-Cook Medical, Inc.1997—
*K013153Autotome RX Model # 4515, 4516Boston Scientific Corp200132
*K970278Microvasive Gold Probe
Summary page 1
…devices including the Wilson- Cook Needle Knife Papillotome (K972674); the Boston Scientific AutotomeTM RX (KO13 153); and the Boston Scientific Microvasive Gold Probe (K970278). Device Description: The Wilson-Cook Cystotome consists of an inner wire with needle knife tip, a 5 Fr inner sheath, and a 10 F…
Boston Scientific Corp1997—

Also cleared against K972674: 3 other devices →

What descends from it? (29)

See all 29

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd.200916
K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp20158
K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation20260
K223256Optimos™ CystotomeTaewoong Medical Co., Ltd.20230
K211909Cysto-Gastro-SetsG-Flex Europe Sprl20220
K093279Navix Access DeviceXlumena20100

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 5 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K092359 (Cook Ireland, Ltd., 2009) has gone furthest, with 16 descendants of its own.
  • 3 other devices also cite its predicate K972674.

How does its category compare?

All KNS devices

KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNS

11in 2025

2007: 12008: 32009: 32010: 42011: 12012: 22013: 22014: 12015: 32016: 32017: 32018: 52019: 72020: 42021: 42022: 32023: 92024: 32025: 112026 (partial year): 2
2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNS

171in 2025

2008: 61 days median2009: 212 days median2010: 168 days median2015: 252 days median2016: 30 days median2017: 48 days median2018: 62 days median2019: 66 days median2020: 212 days median2021: 139 days median2022: 182 days median2023: 83 days median2024: 198 days median2025: 171 days median
2007high 252 (2015) · low 30 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNS

14in 2024

2007: 32008: 52009: 22011: 22016: 62017: 12021: 412024: 142026 (partial year): 4
2007high 41 (2021) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNS

1,504in 2025

2007: 1642008: 5872009: 1,0272010: 9082011: 8602012: 8482013: 4492014: 4052015: 4062016: 4572017: 4462018: 5632019: 6682020: 9062021: 8142022: 9132023: 9762024: 1,5332025: 1,504
2007high 1,533 (2024) · low 164 (2007)2025

MAUDE reports naming product code KNS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—3164
20083615587
2009321221,027
201041680908
20111—2860
20122—0848
20132—0449
20141—0405
201532520406
20163306457
20173481446
20185620563
20197660668
202042120906
2021413941814
202231820913
20239830976
20243198141,533
20251117101,504
20262—4—

What is it indicated for?

The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K972674

3 other devices cite the same predicate.

  • K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy · 2017
  • K061684Medi-Globe Rota-Cut SphincterotomeMedi-Globe Corporation · 2006
  • K040981Usw Needleknife PapillotomeWilson-Cook Medical, Inc. · 2004

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

Recent decisions in KNS

The KNS category page

  • K262460Rezum SystemBoston Scientific · 2026
  • K260962SphincterotomeTaewoong Medical Co., Ltd. · 2026
  • K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc. · 2025
  • K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation · 2025
  • K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V…Olympus Medical Systems Corp. · 202516 recalls

https://510kreport.com/device/K022595 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022595: Wilson-Cook Cystotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022595

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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