Cleared Traditional

K100577 - ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

K100577 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 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

FDA 510(k) Submission Details - K100577

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
221d slower than avg
Panel avg: 90d · This submission: 311d
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 122
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K100577.
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
FINESS ENDOSCOPE
K102366 · Entellus Medical, Inc. · Feb 2011
VISION SCIENCES FLEXIBLE ENT SCOPE
K100125 · Vision-Sciences, Inc. · Feb 2010
CLEARVIEW ENDOSCOPE COVER
K080740 · Invotec International, Inc. · Dec 2008
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · Entellus Medical, Inc. · Sep 2008