510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220073Unknown

Revi System

Bluewind Medical Ltd., Herzliya, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN220073 is the FDA 510(k) clearance record for Revi System, a class II device, cleared for Bluewind Medical , Ltd. on under FDA product code QXM (Implanted Tibial Electrical Urinary Continence Device). FDA's definition for product code QXM reads: "An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle...". FDA records list 4 510(k) clearances for Bluewind Medical , Ltd., from to . As of , FDA records show no recalls naming DEN220073.

Clearance record

Decision date
Received
(315 days to decision)
Product code
QXM Implanted Tibial Electrical Urinary Continence Device
Regulation
21 CFR 876.5305
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bluewind Medical , Ltd. 6 Maskit St., Herzliya, IL
Third party review
No

Clearances, product code QXM

Trailing 12 months
2 clearances under product code QXM in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QXM, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260