Mahe Instruments

FDA 510(k) K942823 · Mahe Intl., Inc.

Substantially Equivalent

510(k) numberK942823

Submission

Device name
Mahe Instruments
Applicant
Mahe Intl., Inc.
Nashville, TN, US
Received
June 14, 1994
Decision date
December 5, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DWG – Electrosurgical Device
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Specialty
General, Plastic Surgery

Other 510(k)s with product code DWG

510(k)DeviceApplicantDecision
K932345Tech-Switch Electrosurgical Pencil, Single UseDWG · Traditional Conmedcorp04/12/1994SE
K931215Hand-Trol SDWG · Traditional Aspen Labs03/28/1994SE
K925708Disposable Electrosurgery Ball ElectrodeDWG · Traditional Beacon Laboratories, Inc.04/20/1993SE

More from Beacon Laboratories, Inc.

510(k)DeviceDecision
K030857Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and Endoscopic…EOB · Traditional 10/16/2003SE
K991426Mahe InstrumentsFDC · Traditional 08/05/1999SE

Questions and answers

When was Mahe Instruments cleared by the FDA?

Mahe Instruments (K942823) received a 510(k) decision of Substantially Equivalent on December 5, 1994, 174 days after the submission was received.

What is the product code of K942823?

The FDA product code is DWG – Electrosurgical Device, a Class II (moderate risk) device regulated under 21 CFR 878.4400.