510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950784Substantially Equivalent

Dristar Urinary Incontinence Management System

Advanced Bioresearch Assoc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950784 is the FDA 510(k) clearance record for DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM, a class I device, cleared for Advanced Bioresearch Assoc. on under FDA product code EYQ (Garment, Protective, For Incontinence). FDA records list 3 510(k) clearances for Advanced Bioresearch Assoc., from to . As of , FDA records show no recalls naming K950784.

Clearance record

Decision date
Received
(71 days to decision)
Product code
EYQ Garment, Protective, For Incontinence
Regulation
21 CFR 876.5920
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Advanced Bioresearch Assoc. 1700 Rockville Pike, Suite 450, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code EYQ

Trailing 12 months

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

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