510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K932809Substantially Equivalent

Frangi-Cath Safe-Release(tm) Connector

Excalibur Engineering Care of Rms, Inc., Palm Florida FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932809 is the FDA 510(k) clearance record for FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR, a class II device, cleared for Excalibur Engineering Care of Rms, Inc. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list one 510(k) clearance for Excalibur Engineering Care of Rms, Inc. As of , FDA records show no recalls naming K932809.

Clearance record

Decision date
Received
(281 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Excalibur Engineering Care of Rms, Inc. P.O. Box 2010, Palm Florida FL
510(k) summary
Statement
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