510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Rotatable Polypectomy Snare Pos-1

K851958510(k) TraditionalCleared Jul 25, 198583-day reviewClass II21 CFR 876.4300Recalls 3

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 Jul 25, 1985 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled 3 times.

Decided
Jul 25, 1985
Review
83 days
Class
Class II
Product code
KNS
Recalls
3
Predicates
0

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

Descendants, by year cleared 2018: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant cleared2007: 1 descendant cleared2019: 1 descendant cleared2011: 1 descendant cleared2013: 2 descendants cleared2014: 2 descendants cleared2026: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK851958 Rotatable Polypectomy Snare Pos-1Wilson-Cook Medical, Inc. · 1985
  2. Descendant · cites it directly · 9 of its ownK050294 Cook Ireland Sonnet Polypectomy SnareCook Ireland, Ltd. · 2005
  3. Descendant · 2 generations on · 7 of its ownK070315 Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
  5. Descendant · cites it directly · 1 of its ownK173673 AcuSnare Polypectomy SnareWilson-Cook Medical, Inc. · 2018
  6. Descendant · 4 generations on · 1 of its ownK122605 PKS BillGyrus Acmi, Inc. · 2012

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12009: 12011: 12012: 12013: 22014: 22018: 12019: 12026: 1
2005high 2 (2013) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all
  • K050294Cook Ireland Sonnet Polypectomy SnareCook Ireland, Ltd. · 2005 · cites it directly9descendants
  • K070315Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007 · 2 generations on7descendants
  • K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011 · 3 generations on3descendants
  • K173673AcuSnare Polypectomy SnareWilson-Cook Medical, Inc. · 2018 · cites it directly1descendant
  • K122605PKS BillGyrus Acmi, Inc. · 2012 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K851958Rotatable Polypectomy Snare Pos-1Wilson-Cook Medical, Inc.1985—
+1K050294Cook Ireland Sonnet Polypectomy SnareCook Ireland, Ltd.2005—
+2K070315Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps20073
+3K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.2011—
+1K173673AcuSnare Polypectomy SnareWilson-Cook Medical, Inc.2018—
+4K122605PKS BillGyrus Acmi, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201110
201210
201320
201420
201810
201910
202610
FIG. 1 — Lineage of K851958, 1985–2026Source: 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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K050294Cook Ireland Sonnet Polypectomy SnareCook Ireland, Ltd.20059
K173673AcuSnare Polypectomy SnareWilson-Cook Medical, Inc.20181

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 4, 2019Class IIZ-1132-2019Nonconforming Material/ComponentComplaints of the snare loop not completely retracting and/or misshaping of the snare loop.
Jan 21, 2009Not classifiedZ-1059-2009Process controlThe snare head is hexagonal but the handle and packaging indicate an oval reorder number.
Apr 21, 2004Not classifiedZ-0906-04OtherThe snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K050294 (Cook Ireland, Ltd., 2005) has gone furthest, with 9 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 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
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https://510kreport.com/device/K851958 · printed Nov 5, 2026

Cite this page

510(k) Report. “K851958: Rotatable Polypectomy Snare Pos-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851958

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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