Cleared Traditional

K923847 - DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS

K923847 is an FDA 510(k) clearance for DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K923847 · Wilson-Cook Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
110d
Days
Class 2
Risk

K923847 is an FDA 510(k) clearance for the DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on November 18, 1992 after a review of 110 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K923847

510(k) Number K923847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1992
Decision Date November 18, 1992
Days to Decision 110 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 90d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

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 243
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K923847.
EVIS 200 SYSTEM
K931154 · Olympus Corp. · Oct 1993
MILL-ROSE PULMONARY FORCEPS
K922204 · Mill-Rose Laboratory · Jul 1993
CANNULATED BIOPSY FORCEPS
K926430 · Thomasville Medical Assoc. · Mar 1993
FLEXIBLE FIBER OPTIC ENDOSCOPE
K922937 · Optimed Technologies, Inc. · Sep 1992
IMAGICA MICRO-ENDOSCOPE
K921393 · Fiberoptic Medical Products, Inc. · Aug 1992
BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY
K915816 · Gi Supply · Mar 1992
K923847 · DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
Download PDF FDA Summary Wilson-Cook Medical, …