510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Olympus KD-6G1-9Q Wire Guided Papillotomu Knife

K950166510(k) TraditionalCleared Feb 22, 199536-day reviewClass II21 CFR 876.4300Recalls 10

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

Olympus America, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Feb 22, 1995 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it. It has been recalled 10 times.

Decided
Feb 22, 1995
Review
36 days
Class
Class II
Product code
KNS
Recalls
10
Predicates
0

21 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2001: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant cleared2015: 3 descendants cleared2016: 1 descendant cleared2020: 2 descendants cleared2025: 3 descendants cleared2019: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 3 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950166 Olympus KD-6G1-9Q Wire Guided Papillotomu KnifeOlympus America, Inc. · 1995
  2. Descendant · cites it directly · 12 of its ownK011149 Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001
  3. Descendant · 2 generations on · 11 of its ownK051504 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2005
  4. Descendant · 2 generations on · 10 of its ownK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
  5. Descendant · 3 generations on · 9 of its ownK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · Recalled
  6. Descendant · 4 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2001: 12005: 12009: 12013: 12015: 32016: 12018: 12019: 22020: 22023: 12024: 12025: 32026: 3
2001high 3 (2015) · low 0 (2002)2026

Most influential descendants

Showing 5 of 21 · See all
  • K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001 · cites it directly12descendants
  • K051504Spyscope Access and Delivery CatheterBoston Scientific Corp · 2005 · 2 generations on11descendants
  • K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · 2 generations on10descendants
  • K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · 3 generations on9descendants
  • K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950166Olympus KD-6G1-9Q Wire Guided Papillotomu KnifeOlympus America, Inc.1995—
+1K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co.2001—
+2K051504Spyscope Access and Delivery CatheterBoston Scientific Corp2005—
+2K090170Spyscope Access and Delivery CatheterBoston Scientific Corp2009—
+3K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation20151
+4K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200510
200910
201310
201530
201610
201810
201920
202020
202310
202410
202530
202630
FIG. 1 — Lineage of K950166, 1995–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co.200112
K122505Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp.20137

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 7, 2026Class IIZ-1292-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1290-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1294-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1295-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1293-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1287-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1289-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1296-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1288-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.
Jan 7, 2026Class IIZ-1291-2026Process controlDevices which did not undergo thermoforming could deform and lose performance.

The 5 latest of 10 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K011149 (The Olympus Optical Co., 2001) has gone furthest, with 12 descendants of its own.

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—

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 recall

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/K950166 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950166: Olympus KD-6G1-9Q Wire Guided Papillotomu Knife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950166

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026