510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011190Substantially Equivalent

Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx Lp System)

Surx, Inc., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011190 is the FDA 510(k) clearance record for SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM), a class II device, cleared for Surx, Inc. on under FDA product code MUK (Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue). FDA's definition for product code MUK reads: "For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence". FDA records list one 510(k) clearance for Surx, Inc. As of , FDA records show no recalls naming K011190.

Clearance record

Decision date
Received
(264 days to decision)
Product code
MUK Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Surx, Inc. 6900 Koll Center Pkwy., #417, Pleasanton CA
510(k) summary
Summary
Third party review
No

Clearances, product code MUK

Trailing 12 months

FDA records hold no clearances under product code MUK in the trailing twelve months.

FDA records show no clearances under product code MUK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MUK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260