Cleared Special

K110097 - ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

K110097 is an FDA 510(k) clearance for ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE, manufactured by Acclarent, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Special 510(k) pathway after a 134-day FDA review.

K110097 · Acclarent, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
134d
Days
Class 2
Risk

K110097 is an FDA 510(k) clearance for the ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on May 27, 2011 after a review of 134 days - within the typical 510(k) review window.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110097

510(k) Number K110097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2011
Decision Date May 27, 2011
Days to Decision 134 days
Submission Type Special
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
44d slower than avg
Panel avg: 90d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

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 162
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K110097.
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · Acclarent, Inc. · Apr 2014
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
K132009 · Schoelly Fiberoptic GmbH · Apr 2014
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
K102733 · Vision-Sciences, Inc. · May 2011
FINESS ENDOSCOPE
K102366 · Entellus Medical, Inc. · Feb 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577 · Acclarent, Inc. · Jan 2011
K110097 · ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
Download PDF FDA Summary Acclarent, Inc.