510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K082919Substantially Equivalent

Uc-Care Positioning System

Uc-Care Medical Systems, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082919 is the FDA 510(k) clearance record for UC-CARE POSITIONING SYSTEM, a class II device, cleared for Uc-Care Medical Systems, Ltd. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list one 510(k) clearance for Uc-Care Medical Systems, Ltd. As of , FDA records show no recalls naming K082919.

Clearance record

Decision date
Received
(27 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Uc-Care Medical Systems, Ltd. 555 13th St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZL

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