510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864592Substantially Equivalent

Judd Urethal Catheter Container

Phil Judd, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864592 is the FDA 510(k) clearance record for JUDD URETHAL CATHETER CONTAINER, a class II device, cleared for Phil Judd, Inc. on under FDA product code KOD (Catheter, Urological). FDA records list one 510(k) clearance for Phil Judd, Inc. As of , FDA records show no recalls naming K864592.

Clearance record

Decision date
Received
(215 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Phil Judd, Inc. 1500 SW 5th Ave., Suite 1806, Portland OR
Third party review
No

Clearances, product code KOD

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