510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944383Substantially Equivalent

Orion Red Urethral Catheter

Regulatory & Marketing Services, Inc., Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944383 is the FDA 510(k) clearance record for ORION RED URETHRAL CATHETER, a class II device, cleared for Regulatory & Marketing Services, Inc. on under FDA product code EZD (Catheter, Straight). FDA records list 22 510(k) clearances for Regulatory & Marketing Services, Inc., from to . As of , FDA records show no recalls naming K944383.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Regulatory & Marketing Services, Inc. 1247 Florida Ave., Palm Harbor FL
510(k) summary
Statement
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