Cleared Special

K110097 - ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

K110097 is the FDA 510(k) clearance for ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE by Acclarent, Inc.. It is a Class 2 Ear, Nose, Throat device (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)
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.

View all Acclarent, Inc. devices

Submission Details

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
45d slower than avg
Panel avg: 89d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 82
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K110097.
TIPCAM 1S 3D System
K162410 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · Acclarent, Inc. · Apr 2014
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577 · Acclarent, Inc. · Jan 2011
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387 · KARL STORZ Endoscopy-America, Inc. · Sep 2007
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K070752 · KARL STORZ Endoscopy-America, Inc. · May 2007