Cleared Traditional

K944671 - VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})

K944671 is an FDA 510(k) clearance for VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {..., manufactured by Jedmed Instrument Co.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K944671 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K944671

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 90d · This submission: 138d
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 133
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