510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K113771Substantially Equivalent

Signal Gear Urethral Catheter Electrode

Neurovision Medical Products Inc, Ventura CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113771 is the FDA 510(k) clearance record for SIGNAL GEAR URETHRAL CATHETER ELECTRODE, a class II device, cleared for Neurovision Medical Products, Inc. on under FDA product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device). FDA records list 9 510(k) clearances for Neurovision Medical Products, Inc., from to . As of , FDA records show 2 recalls naming K113771.

Clearance record

Decision date
Received
(357 days to decision)
Product code
FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000, Ventura CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FAP

Trailing 12 months

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

FDA records show no clearances under product code FAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAP, 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