Benson CCA100

FDA 510(k) K924652 · Benson Medical Instruments Co.

Substantially Equivalent

510(k) numberK924652

Submission

Device name
Benson CCA100
Applicant
Benson Medical Instruments Co.
Minneapolis, MN, US
Received
September 15, 1992
Decision date
April 9, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EWG – Laser, Ent Microsurgical Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4500
Specialty
Ear, Nose, Throat

Other 510(k)s with product code EWG

510(k)DeviceApplicantDecision
K870587Lasermatic Surgilaser Model 5050EWG · Traditional Lasermatic OY08/10/1988SN
K880429Illumina 55 CO2 Laser SystemEWG · Traditional Cooper Lasersonics, Inc.04/18/1988SE
K880428Illumina 25 CO2 Laser SystemEWG · Traditional Cooper Lasersonics, Inc.04/18/1988SE
K880427Illumina 40 CO2 Laser SystemEWG · Traditional Cooper Lasersonics, Inc.04/18/1988SE
K872710Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional Directed Energy, Inc.09/24/1987SE
K870840Model 20-C W/BR-20A/U Attach/Model HL-3.O AttachEWG · Traditional Directed Energy, Inc.06/12/1987SE
K864975Laserscope Omniplus Photosurgical System for (ENT)EWG · Traditional Laserscope02/25/1987SE
K862866Model 10-C W/LP-10A/U & OS-10A/U for Oral/Ent UseEWG · Traditional Directed Energy, Inc.01/09/1987SE
K862865Model 10-C W/LP-10A/U & OB-10A/U for Oral/Ent UseEWG · Traditional Directed Energy, Inc.01/09/1987SE
K862150Model 8-B with OS-1 Attachment (C02 Laser for ENT)EWG · Traditional Directed Energy, Inc.09/04/1986SN

More from Directed Energy, Inc.

510(k)DeviceDecision
K123896CCS-200 SpirometerBZG · Traditional 09/10/2013SE
K982441CCA-220EWO · Traditional 10/09/1998SE
K981439CCA-200EWO · Traditional 06/15/1998SE
K963681CCA-100 (Modified)EWO · Traditional 10/08/1996SE

Questions and answers

When was Benson CCA100 cleared by the FDA?

Benson CCA100 (K924652) received a 510(k) decision of Substantially Equivalent on April 9, 1993, 206 days after the submission was received.

What is the product code of K924652?

The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.