Cleared Traditional

K100577 - ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

K100577 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 Traditional 510(k) pathway after a 311-day FDA review.

K100577 · Acclarent, Inc. · Ear, Nose, Throat device
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Jan 2011
Decision
311d
Days
Class 2
Risk

K100577 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 January 6, 2011 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Acclarent, Inc. devices

Submission Details

510(k) Number K100577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2010
Decision Date January 06, 2011
Days to Decision 311 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
222d slower than avg
Panel avg: 89d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K100577.
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
K110097 · Acclarent, Inc. · May 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
MICROENDOSCOPE
K063078 · Acclarent, Inc. · Oct 2006