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510(k) K011190

Device
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
Applicant
SURX, INC.
510(k) number
K011190
Product code
MUK  
Decision
Substantially Equivalent (SESE)
Decision date
2002-01-08
Date received
2001-04-19
Regulation
878.4400
Classification name
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
Medical specialty
General & Plastic Surgery
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ALAN CURTIS
Address
6900 Koll Center Pkwy., #417 Pleasanton CA US 94566 94566

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MUK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020952SURX RF SYSTEMSurx, Inc.2002-05-30
K020126MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)Surx, Inc.2002-03-15

Legacy Summary#

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FDA Review#

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