510(k) Report

510(k) · Cleared

Cleared

Finess Sinus Treatment System (Access Sheath Component)

K091681510(k) SpecialCleared Jul 8, 200928-day reviewClass I21 CFR 874.4420

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

Entellus Medical, Inc. · LRC Instrument, Ent Manual Surgical

Cleared on Jul 8, 2009 after a 28-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided
Jul 8, 2009
Review
28 days
Class
Class I
Product code
LRC
Recalls
None
Predicates
1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K091681Source: FDA 510(k) database · 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 LRC? 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 LRC device

  1. #1 K230258 BB 8 Sinus Dilation Kitscore 11.1 · 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? (1)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK073202FDA’s K073202 is Ardis Spacer
Our reading of the summary gave K073202, FDA’s number for Ardis Spacer (Abbott Spine, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “FinESS Sinus Treatment”. Kept off the family tree.
Summary page 1
…: LRC Regulation Number: Class I,21 CFR 874.4420 Predicate Device: FinESS Sinus Treatment (K073202) Device Description: The access sheath component of the FinESS Sinus Treatment System iscomprised of a polycarbonate fla…
Abbott Spine, Inc.2008Class I

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.

How does its category compare?

All LRC devices

LRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LRC

1in 2023

2008: 22009: 12010: 22011: 62012: 72013: 72014: 32015: 62016: 32017: 22018: 12019: 12020: 42022: 12023: 1
2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRC

131in 2020

2011: 106 days median2012: 50 days median2013: 104 days median2014: 29 days median2015: 105 days median2016: 100 days median2020: 131 days median
2007high 131 (2020) · low 29 (2014)2026

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

Recalls per year · LRC

1in 2024

2023: 12024: 1
2007high 1 (2023) · low 0 (2007)2026

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

Adverse event reports per year · LRC

44in 2025

2007: 12009: 82010: 112011: 142012: 482013: 532014: 532015: 412016: 392017: 322018: 422019: 192020: 202021: 232022: 252023: 142024: 512025: 44
2007high 53 (2013) · low 0 (2008)2025

MAUDE reports naming product code LRC, 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—01
20082—00
20091—08
20102—011
20116106014
2012750048
20137104053
2014329053
20156105041
20163100039
20172—032
20181—042
20191—019
20204131020
20210—023
20221—025
20231—114
20240—151
20250—044
20260—0—

What is it indicated for?

FinESS is indicated to access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Indications for use as stated in the FDA summary.

More from Entellus Medical, Inc.

27 FDA decisions under this applicant name. See the company

  • K220027Audion ET dilation systemEntellus Medical, Inc. · 2022
  • K163509XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
  • K163435Entellus Medical Reinforced Anesthesia NeedleEntellus Medical, Inc. · 2017
  • K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
  • K152435PassAssist LED Light FiberEntellus Medical, Inc. · 2015

Recent decisions in LRC

The LRC category page

  • K230258BB 8 Sinus Dilation KitExcelent, Inc. · 2023
  • K212774VenSure LightGuideIntersect Ent. · 2022
  • K201398SINUSPRIME Dilation SystemStryker Ent · 2020
  • K201115Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020
  • K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH · 2020

https://510kreport.com/device/K091681 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091681: Finess Sinus Treatment System (Access Sheath Component).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091681

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026