Cleared Traditional

GALILEO ENDOSCOPES (K962116) - FDA 510(k) Clearance

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

K962116 · Galileo Electro-Optics Corp. · Ear, Nose, Throat device
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Nov 1996
Decision
180d
Days
Class 2
Risk

K962116 is an FDA 510(k) clearance for the GALILEO ENDOSCOPES. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Galileo Electro-Optics Corp. (North Attleboro, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 180 days - an extended review 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. 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 Galileo Electro-Optics Corp. devices

Submission Details

510(k) Number K962116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1996
Decision Date November 27, 1996
Days to Decision 180 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
91d slower than avg
Panel avg: 89d · This submission: 180d
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 K962116.
DCI ENDOSCOPE
K984369 · KARL STORZ Endoscopy-America, Inc. · Jan 1999
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855 · KARL STORZ Endoscopy-America, Inc. · Sep 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · Smith & Nephew, Inc. · Mar 1997
IRRIGATION/SUCTION HANDLE AND SHEATH
K963757 · Richard Wolf Medical Instruments Corp. · Nov 1996
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
KSEA BIPOLAR GOAGULATING FORCEPS
K962396 · KARL STORZ Endoscopy-America, Inc. · Aug 1996