Cleared Traditional

VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (K944671) - FDA 510(k) Clearance

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

K944671 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Feb 1995
Decision
138d
Days
Class 2
Risk

K944671 is an FDA 510(k) clearance for the VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}). Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 138 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K944671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date February 07, 1995
Days to Decision 138 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
49d slower than avg
Panel avg: 89d · This submission: 138d
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 K944671.
KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS
K950338 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE
K944861 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES
K946148 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES
K945788 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES
K945381 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
OLYMPUS NASAL AND SINUS ENDOSCOPES
K944072 · Olympus America, Inc. · Jan 1995