FDA.reportPublic FDA data

510(k) K101592

Device
ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
Applicant
Cheng Medical, Corporation
510(k) number
K101592
Product code
GXD
Decision
Substantially Equivalent (SESE)
Decision date
2011-10-06
Date received
2010-06-07
Regulation
882.4400
Classification name
Generator, Lesion, Radiofrequency
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARY P GALLUP
Address
12945 Saratoga Ave. Saratoga CA US 95070 95070

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K111576NT 2000 LESIONING GENERATORNeuro Therm, Inc.2011-09-20
K093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)Diros Technology, Inc.2010-01-22
K082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4Cosman Medical, Inc.2008-10-16
K081729MODIFICATION TO GFX NERVE ABLATION SYSTEMBioform Medical, Inc.2008-08-07