Cleared Traditional

TRANSTYMPANIC ENDOSCOPE (K945081) - FDA 510(k) Clearance

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

K945081 · Endooptiks, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
140d
Days
Class 2
Risk

K945081 is an FDA 510(k) clearance for the TRANSTYMPANIC ENDOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Endooptiks, Inc. (Little Silver, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 140 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 Endooptiks, Inc. devices

Submission Details

510(k) Number K945081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1994
Decision Date March 06, 1995
Days to Decision 140 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 89d · This submission: 140d
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 160
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