510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K221593Substantially Equivalent

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus

ConvaTec Limited, Greensboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221593 is the FDA 510(k) clearance record for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus, a class II device, cleared for Convatec, Inc. on under FDA product code EZD (Catheter, Straight). FDA records list 29 510(k) clearances for Convatec, Inc., from to . As of , FDA records show no recalls naming K221593.

Clearance record

Decision date
Received
(168 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Convatec, Inc. 7815 National Service Rd.,, Greensboro NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZD

Trailing 12 months
11 clearances under product code EZD in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20261
April 20262
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260