Cleared Traditional

K944670 - JARIT RECOMMENDED SINUS INSTRUMENTS

K944670 is the FDA 510(k) clearance for JARIT RECOMMENDED SINUS INSTRUMENTS by J. Jamner Surgical Instruments, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K944670 · J. Jamner Surgical Instruments, Inc. · Ear, Nose, Throat device
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Feb 1995
Decision
133d
Days
Class 2
Risk

K944670 is an FDA 510(k) clearance for the JARIT RECOMMENDED SINUS INSTRUMENTS. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by J. Jamner Surgical Instruments, Inc. (Hawthorne, US). The FDA issued a Cleared decision on February 2, 1995 after a review of 133 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 J. Jamner Surgical Instruments, Inc. devices

Submission Details

510(k) Number K944670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date February 02, 1995
Days to Decision 133 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
44d slower than avg
Panel avg: 89d · This submission: 133d
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 106
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K944670.
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
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
K944671 · Jedmed Instrument Co. · 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