Cleared Traditional

K070580 - NASOPHARYNGOSCOPE

K070580 is an FDA 510(k) clearance for NASOPHARYNGOSCOPE, manufactured by Xion GmbH. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K070580 · Xion GmbH · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
104d
Days
Class 2
Risk

K070580 is an FDA 510(k) clearance for the NASOPHARYNGOSCOPE, BRONCHOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Xion GmbH (Berlin, DE). The FDA issued a Cleared decision on June 13, 2007 after a review of 104 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 Xion GmbH devices

FDA 510(k) Submission Details - K070580

510(k) Number K070580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2007
Decision Date June 13, 2007
Days to Decision 104 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
15d slower than avg
Panel avg: 89d · This submission: 104d
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 106
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K070580.
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · Entellus Medical, Inc. · Sep 2008
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387 · KARL STORZ Endoscopy-America, Inc. · Sep 2007
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
K072073 · Vision-Sciences, Inc. · Aug 2007
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K070752 · KARL STORZ Endoscopy-America, Inc. · May 2007
MICROENDOSCOPE
K063078 · Acclarent, Inc. · Oct 2006
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452 · Olympus Medical Systems Corporation · Sep 2005