Cleared Traditional

K884933 - ENDOSTROBOSCOPE IV

K884933 is the FDA 510(k) clearance for ENDOSTROBOSCOPE IV by Jedmed Instrument Co.. It is a Class 1 Ear, Nose, Throat device (product code EQL) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K884933 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Feb 1989
Decision
79d
Days
Class 1
Risk

K884933 is an FDA 510(k) clearance for the ENDOSTROBOSCOPE IV. Classified as Laryngostroboscope (product code EQL), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on February 15, 1989 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jedmed Instrument Co. devices

Submission Details

510(k) Number K884933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date February 15, 1989
Days to Decision 79 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 89d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQL Laryngostroboscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EQL Laryngostroboscope

Devices cleared under the same product code (EQL) and FDA review panel - the closest regulatory comparables to K884933.
RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351
K984521 · Richard Wolf Medical Instruments Corp. · Mar 1999
LARYNGOSTROBOSCOPE
K822523 · Kelleher Corp. · Sep 1982
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
K801866 · Pentax Precision Instrument Corp. · Sep 1980
STOCKINGS, RVS TM
K770466 · Parke-Davis Co. · Mar 1977