Cleared Traditional

K921393 - IMAGICA MICRO-ENDOSCOPE

K921393 is the FDA 510(k) clearance for IMAGICA MICRO-ENDOSCOPE by Fiberoptic Medical Products, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K921393 · Fiberoptic Medical Products, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 1992
Decision
150d
Days
Class 2
Risk

K921393 is an FDA 510(k) clearance for the IMAGICA MICRO-ENDOSCOPE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Fiberoptic Medical Products, Inc. (Philadelphia, US). The FDA issued a Cleared decision on August 20, 1992 after a review of 150 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - 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 Fiberoptic Medical Products, Inc. devices

Submission Details

510(k) Number K921393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1992
Decision Date August 20, 1992
Days to Decision 150 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
61d slower than avg
Panel avg: 89d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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 - EOQ Bronchoscope (flexible Or Rigid)

All 150
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K921393.
RICHARD ROD LENS LARYNGOSCOPE
K941264 · Smith & Nephew Richards, Inc. · Jul 1994
EVIS 200 SYSTEM
K931154 · Olympus Corp. · Oct 1993
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K923847 · Wilson-Cook Medical, Inc. · Nov 1992
OLYMPUS DISPOSABLE SUCTION VALVE
K920025 · Olympus Corp. · Mar 1992
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412 · Olympus Corp. · Jun 1991
BRONCHOSCOPE BF-N20
K910423 · Olympus Corp. · Apr 1991