510(k) Report

510(k) · Cleared

Cleared

AcuSnare Polypectomy Snare

K173673510(k) TraditionalCleared Aug 24, 2018267-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. · FDI Snare, Flexible

Cleared on Aug 24, 2018 as substantially equivalent to K851958 (Wilson-Cook Medical, Inc., 1985) and 1 other predicate after a 267-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.

Decided
Aug 24, 2018
Review
267 days
Class
Class II
Product code
FDI
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K950496 (1995). 8 ancestors in all, the oldest K851958 (1985). 1 later device descends from it, 1 citing it directly.

  1. Root · 5 generations backK950496 Snare, Flexible, Electrosurgical Cutting & Coagulation Device &…Boston Scientific Corp · 1995
  2. 4 generations backK992477 RotosnareInscope, LLC · 1999
  3. 3 generations backK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
  4. 2 generations backK133987 Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · Recalled
  5. 1 generation backK172734 Single Use Electrosurgical Snare SD-400Olympus Medical Systems Corp. · 2017 · Recalled
  6. This deviceK173673 AcuSnare Polypectomy SnareWilson-Cook Medical, Inc. · 2018
  7. Descendant · cites it directly · 0 of its ownK191048 AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K191048AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K950496Snare, Flexible, Electrosurgical Cutting & Coagulation Device & AccessoriesBoston Scientific Corp1995—
−4K992477RotosnareInscope, LLC1999—
−3K131700Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile…Boston Scientific Corp20138
−2K133987Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation20141
−1K172734Single Use Electrosurgical Snare SD-400Olympus Medical Systems Corp.201741
0 (this device)K173673AcuSnare Polypectomy SnareWilson-Cook Medical, Inc.2018—
+1K191048AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K173673, 1995–2019Source: 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 FDI? 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 FDI device

  1. #1 K251692 Advanced Tissue Resection Devicescore 10.9 · 1 generation · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K851958Rotatable Polypectomy Snare Pos-1
Summary page 4
…: Class II Classification Panel: Gastroenterology and urology Classification Name: snare, flexible Predicate Devices: Rotatable Polypectomy Snare (POS-1) K851958; cleared July 25, 1985 Single Use Electrosurgical Snare (SD-400) K172734; cleared December 7, 2017 Inten…
Wilson-Cook Medical, Inc.19853
*K172734Single Use Electrosurgical Snare SD-400
Cleared while this submission was under review
Summary page 4
…, flexible Predicate Devices: Rotatable Polypectomy Snare (POS-1) K851958; cleared July 25, 1985 Single Use Electrosurgical Snare (SD-400) K172734; cleared December 7, 2017 Intended Use: This subject device is used endoscopically in the removal and cauterization of sessile po…
Olympus Medical Systems Corp.201741

Also cleared against K851958: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191048AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc.20190

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 3.9 years on median.
  • 6 of the 8 ancestors have a recall of any class.
  • Of its descendants, K191048 (Wilson-Cook Medical, Inc., 2019) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K851958.

How does its category compare?

All FDI devices

FDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · FDI

1in 2023

2008: 22009: 12011: 12012: 12013: 32014: 52015: 32016: 12017: 12018: 42019: 32020: 22021: 12022: 42023: 12026 (partial year): 1
2007high 5 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDI

247in 2022

2013: 87 days median2014: 47 days median2015: 62 days median2018: 214 days median2019: 100 days median2022: 247 days median
2007high 247 (2022) · low 47 (2014)2026

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

Recalls per year · FDI

2in 2025

2010: 12015: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · FDI

274in 2025

2007: 482008: 2012009: 2652010: 1742011: 1772012: 1622013: 1912014: 3452015: 1952016: 2232017: 1542018: 1812019: 1352020: 4872021: 2112022: 2462023: 2092024: 2792025: 274
2007high 487 (2020) · low 48 (2007)2025

MAUDE reports naming product code FDI, 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
20070—048
20082—0201
20091—0265
20100—1174
20111—0177
20121—0162
20133870191
20145470345
20153621195
20161—0223
20171—0154
201842140181
201931000135
20202—0487
20211—0211
202242470246
20231—0209
20240—0279
20250—2274
20261—0—

What is it indicated for?

This device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K173673: AcuSnare Polypectomy Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173673

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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