Cleared Traditional

K102366 - FINESS ENDOSCOPE

K102366 is an FDA 510(k) clearance for FINESS ENDOSCOPE, manufactured by Entellus Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K102366 · Entellus Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
179d
Days
Class 2
Risk

K102366 is an FDA 510(k) clearance for the FINESS ENDOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 15, 2011 after a review of 179 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Entellus Medical, Inc. devices

FDA 510(k) Submission Details - K102366

510(k) Number K102366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2010
Decision Date February 15, 2011
Days to Decision 179 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 89d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOB Device Classification - Class 2, Special Controls

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOB Nasopharyngoscope (flexible Or Rigid)

All 109
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K102366.
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K110097 · Acclarent, Inc. · May 2011
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
K102733 · Vision-Sciences, Inc. · May 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577 · Acclarent, Inc. · Jan 2011
VISION SCIENCES FLEXIBLE ENT SCOPE
K100125 · Vision-Sciences, Inc. · Feb 2010
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · Entellus Medical, Inc. · Sep 2008