510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964219Substantially Equivalent

Zip Condom Catheter

Goulter Medical, Inc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964219 is the FDA 510(k) clearance record for ZIP CONDOM CATHETER, a class I device, cleared for Goulter Medical, Inc. on under FDA product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile). FDA records list one 510(k) clearance for Goulter Medical, Inc. As of , FDA records show no recalls naming K964219.

Clearance record

Decision date
Received
(293 days to decision)
Product code
EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Goulter Medical, Inc. 1000 Burnett Ave., Suite 450, Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code EYZ

Trailing 12 months

FDA records hold no clearances under product code EYZ in the trailing twelve months.

FDA records show no clearances under product code EYZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EYZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260