Cleared Traditional

K153701 - ULYSS Multi View Sinuscope

K153701 is an FDA 510(k) clearance for ULYSS Multi View Sinuscope, manufactured by Sopro-Comeg GmbH. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K153701 · Sopro-Comeg GmbH · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Sep 2016
Decision
261d
Days
Class 2
Risk

K153701 is an FDA 510(k) clearance for the ULYSS Multi View Sinuscope. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Sopro-Comeg GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on September 9, 2016 after a review of 261 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 Sopro-Comeg GmbH devices

FDA 510(k) Submission Details - K153701

510(k) Number K153701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date September 09, 2016
Days to Decision 261 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 89d · This submission: 261d
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 106
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K153701.
KARL STORZ Slim Nasopharyngolaryngoscope
K171402 · KARL STORZ Endoscopy-America, Inc. · Feb 2018
PENTAX Medical ENT Video Imaging System
K162151 · Pentax of America, Inc. · Apr 2017
TIPCAM 1S 3D System
K162410 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
ULTRA Telescopes
K153009 · Olympus Winter & Ibe GmbH · Apr 2016
InstaClear Lens Cleaner
K152531 · Gyrus Acmi, Inc. · Jan 2016
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · Acclarent, Inc. · Apr 2014