Cleared Traditional

K926430 - CANNULATED BIOPSY FORCEPS

K926430 is an FDA 510(k) clearance for CANNULATED BIOPSY FORCEPS, manufactured by Thomasville Medical Assoc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K926430 · Thomasville Medical Assoc. · Ear, Nose, Throat device
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Mar 1993
Decision
93d
Days
Class 2
Risk

K926430 is an FDA 510(k) clearance for the CANNULATED BIOPSY FORCEPS. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on March 26, 1993 after a review of 93 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.

View all Thomasville Medical Assoc. devices

FDA 510(k) Submission Details - K926430

510(k) Number K926430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date March 26, 1993
Days to Decision 93 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
4d slower than avg
Panel avg: 89d · This submission: 93d
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 187
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K926430.
MODIFIED BRONCHOSCOPE AND ACCESSORIES
K933433 · Fujinon, Inc. · Nov 1993
EVIS 200 SYSTEM
K931154 · Olympus Corp. · Oct 1993
MILL-ROSE PULMONARY FORCEPS
K922204 · Mill-Rose Laboratory · Jul 1993
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K923847 · Wilson-Cook Medical, Inc. · Nov 1992
OLYMPUS DISPOSABLE SUCTION VALVE
K920025 · Olympus Corp. · Mar 1992
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
K914181 · Mill-Rose Laboratory · Dec 1991