Cleared Special

VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (K021073) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021073 · Olympus America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
29d
Days
Class 2
Risk

K021073 is an FDA 510(k) clearance for the VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on May 1, 2002 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K021073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date May 01, 2002
Days to Decision 29 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 89d · This submission: 29d
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 62
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K021073.
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
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
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · KARL STORZ Endoscopy-America, Inc. · Jan 2002
KSEA UNIMAT 12
K002700 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
DCI ENDOSCOPE
K984369 · KARL STORZ Endoscopy-America, Inc. · Jan 1999