510(k) Report

510(k) · Cleared

Cleared

Ethicon Endo Surgery Articulating Snare

K073288510(k) TraditionalCleared Jun 12, 2008204-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

Ethicon Endo-Surgery, Inc. · FDI Snare, Flexible

Cleared on Jun 12, 2008 as substantially equivalent to K992477 (Inscope, LLC, 1999) and 1 other predicate after a 204-day review. Its family tree reaches back 2 generations to 1995.

Decided
Jun 12, 2008
Review
204 days
Class
Class II
Product code
FDI
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K950496 (1995). 3 ancestors in all, the oldest K941750 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorK950496 · Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories · Boston Scientific Corp · 1995K992477 · Rotosnare · Inscope, LLC · 199919901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor K992477 · Rotosnare · Inscope, LLC · 1999K950496 · Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories · Boston Scientific Corp · 19950
  1. Root · 2 generations backK950496 Snare, Flexible, Electrosurgical Cutting & Coagulation Device &…Boston Scientific Corp · 1995
  2. 1 generation backK992477 RotosnareInscope, LLC · 1999
  3. This deviceK073288 Ethicon Endo Surgery Articulating SnareEthicon Endo-Surgery, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K950496Snare, Flexible, Electrosurgical Cutting & Coagulation Device & AccessoriesBoston Scientific Corp1995—
−1K992477RotosnareInscope, LLC1999—
0 (this device)K073288Ethicon Endo Surgery Articulating SnareEthicon Endo-Surgery, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K073288, 1995–2008Source: 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
*K992477Rotosnare
Summary page 1
…Classification Name: Endoscopic electrosurgical unit and accessories (21 CFR 876.4300, Product Code FDI) Predicate Devices Rotatable Snare (K992477) Single-Use Polypectomy Snare (K941750) Device Description The Ethicon Endo Surgery® Articulating Snare consist…
Inscope, LLC1999—
*K941750Proposed Trademan Microvasive Polypectomy Snares
Summary page 1
…ical unit and accessories (21 CFR 876.4300, Product Code FDI) Predicate Devices Rotatable Snare (K992477) Single-Use Polypectomy Snare (K941750) Device Description The Ethicon Endo Surgery® Articulating Snare consists of a flexible wire cable and loop, which can be extende…
Boston Scientific Corp19943

Also cleared against K992477: 1 other device →

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 13 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • 1 other device also cites its predicate K992477.

How does its category compare?

All FDI devices

FDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

The Articulating Snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K073288: Ethicon Endo Surgery Articulating Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073288

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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