Cleared Traditional

SINUSCOPE AND BACCESSORIES (K002214) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002214 · Pollux Endoscopy, Inc. · Ear, Nose, Throat device
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Nov 2000
Decision
120d
Days
Class 2
Risk

K002214 is an FDA 510(k) clearance for the SINUSCOPE AND BACCESSORIES. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Pollux Endoscopy, Inc. (Plant City, US). The FDA issued a Cleared decision on November 21, 2000 after a review of 120 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. 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 Pollux Endoscopy, Inc. devices

Submission Details

510(k) Number K002214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date November 21, 2000
Days to Decision 120 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
31d slower than avg
Panel avg: 89d · This submission: 120d
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 67
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K002214.
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K070752 · KARL STORZ Endoscopy-America, Inc. · May 2007
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · Olympus America, Inc. · May 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · KARL STORZ Endoscopy-America, Inc. · Jan 2002
KSEA UNIMAT 12
K002700 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
K992526 · Richard Wolf Medical Instruments Corp. · Sep 1999
DCI ENDOSCOPE
K984369 · KARL STORZ Endoscopy-America, Inc. · Jan 1999