Cleared Traditional

K924652 - BENSON CCA100

K924652 is an FDA 510(k) clearance for BENSON CCA100, manufactured by Benson Medical Instruments Co.. The device is a Class 2 Ear, Nose, Throat device with product code EWG cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K924652 · Benson Medical Instruments Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
206d
Days
Class 2
Risk

K924652 is an FDA 510(k) clearance for the BENSON CCA100. Classified as Laser, Ent Microsurgical Carbon-dioxide (product code EWG), Class II - Special Controls.

Submitted by Benson Medical Instruments Co. (Minneapolis, US). The FDA issued a Cleared decision on April 9, 1993 after a review of 206 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4500 - 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 Benson Medical Instruments Co. devices

FDA 510(k) Submission Details - K924652

510(k) Number K924652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1992
Decision Date April 09, 1993
Days to Decision 206 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
117d slower than avg
Panel avg: 89d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWG Device Classification - Class 2, Special Controls

Product Code EWG Laser, Ent Microsurgical Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4500
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 - EWG Laser, Ent Microsurgical Carbon-dioxide

All 14
Devices cleared under the same product code (EWG) and FDA review panel - the closest regulatory comparables to K924652.
ILLUMINA 40 CO2 LASER SYSTEM
K880427 · Cooper Lasersonics, Inc. · Apr 1988
ILLUMINA 25 CO2 LASER SYSTEM
K880428 · Cooper Lasersonics, Inc. · Apr 1988
ILLUMINA 55 CO2 LASER SYSTEM
K880429 · Cooper Lasersonics, Inc. · Apr 1988
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
K872710 · Directed Energy, Inc. · Sep 1987
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
K870840 · Directed Energy, Inc. · Jun 1987
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
K864975 · Laserscope · Feb 1987