510(k) Report

510(k) · Cleared

Cleared

Medi-Globe Rota-Cut Sphincterotome

K061684510(k) TraditionalCleared Jun 27, 200612-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

Medi-Globe Corporation · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Jun 27, 2006 as substantially equivalent to K943629 (Medi-Globe Corp., 1995) and 4 other predicates after a 12-day review. Its family tree reaches back 3 generations to 1997.

Decided
Jun 27, 2006
Review
12 days
Class
Class II
Product code
KNS
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K970053 (1997). 7 ancestors in all, the oldest K901443 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 2 other ancestors1995: 1 other ancestor1990: 1 other ancestorK970053 · Ultratomerx · Boston Scientific Corp · 1997K013153 · Autotome RX Model # 4515, 4516 · Boston Scientific Corp · 2001 · recalledK033203 · Wilson-Cook Tri-Tome Select Plus · Wilson-Cook Medical, Inc. · 20031990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K033203 · Wilson-Cook Tri-Tome Select Plus · Wilson-Cook Medical, Inc. · 2003K013153 · Autotome RX Model # 4515, 4516 · Boston Scientific Corp · 2001 · recalledK970053 · Ultratomerx · Boston Scientific Corp · 19970
  1. Root · 3 generations backK970053 UltratomerxBoston Scientific Corp · 1997
  2. 2 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
  3. 1 generation backK033203 Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc. · 2003
  4. This deviceK061684 Medi-Globe Rota-Cut SphincterotomeMedi-Globe Corporation · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K970053UltratomerxBoston Scientific Corp1997—
−2K013153Autotome RX Model # 4515, 4516Boston Scientific Corp200132
−1K033203Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc.2003—
0 (this device)K061684Medi-Globe Rota-Cut SphincterotomeMedi-Globe Corporation2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199720
FIG. 1 — Lineage of K061684, 1997–2006Source: 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
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What was it cleared against? (5)

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
*K943629Gip/Medi-Globe Papillotome
Summary page 1
…Contact Person's FAX Number: (480) 897-2878 B.Device Name: Medi-Globe Rota-Cut®& Sphincterotome C.Predicate Devices: GIP/Medi-Globe Papillotome (K943629/A) Boston Scientific Needle Knife Sphincterotome (K973 826) AutoTome RX Model (K01 3 153) Wilson-Cook Medical Needle Knife Papi…
Medi-Globe Corp.1995—
*K973826Sphincterotome
Summary page 1
…e: Medi-Globe Rota-Cut®& Sphincterotome C.Predicate Devices: GIP/Medi-Globe Papillotome (K943629/A) Boston Scientific Needle Knife Sphincterotome (K973 826) AutoTome RX Model (K01 3 153) Wilson-Cook Medical Needle Knife Papillotome (K972674) Tni-Tome Select Plus (K033203) DODevice…
Boston Scientific Corp1997—
*K013153Autotome RX Model # 4515, 4516
Summary page 1
…Sphincterotome C.Predicate Devices: GIP/Medi-Globe Papillotome (K943629/A) Boston Scientific Needle Knife Sphincterotome (K973 826) AutoTome RX Model (K01 3 153) Wilson-Cook Medical Needle Knife Papillotome (K972674) Tni-Tome Select Plus (K033203) DODevice Description: The proposed Med…
Boston Scientific Corp200132
*K972674Wilson-Cook Needle Knife Papillotome
Summary page 1
…Medi-Globe Papillotome (K943629/A) Boston Scientific Needle Knife Sphincterotome (K973 826) AutoTome RX Model (K01 3 153) Wilson-Cook Medical Needle Knife Papillotome (K972674) Tni-Tome Select Plus (K033203) DODevice Description: The proposed Medi-Globe Rota-Cut® Sphincterotome is available in single,…
Wilson-Cook Medical, Inc.1997—
*K033203Wilson-Cook Tri-Tome Select Plus
Summary page 1
…/A) Boston Scientific Needle Knife Sphincterotome (K973 826) AutoTome RX Model (K01 3 153) Wilson-Cook Medical Needle Knife Papillotome (K972674) Tni-Tome Select Plus (K033203) DODevice Description: The proposed Medi-Globe Rota-Cut® Sphincterotome is available in single, double or triple lumnen models…
Wilson-Cook Medical, Inc.2003—

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 9 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
  • 2 of the 7 ancestors have a recall of any class.

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 Medi-Globe Rota-Cut® Sphincterotome is intended for transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi.

Indications for use as stated in the FDA summary.

More from Medi-Globe Corporation

7 FDA decisions under this applicant name. See the company

  • K153264EasyPass GuidewireMedi-Globe Corporation · 2016
  • K142258PolyCatch Retrieval DeviceMedi-Globe Corporation · 2014
  • K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation · 2014
  • K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation · 2009
  • K083802Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025Medi-Globe Corporation · 2009

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/K061684 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061684: Medi-Globe Rota-Cut Sphincterotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061684

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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