510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961906Substantially Equivalent

Uni-Gard Quik Cath(sizes 8 French Through 18)Ug 10008,10010,10012,10014,10016,10018

Spectrum Medsystems Corp., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961906 is the FDA 510(k) clearance record for UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018, a class I device, cleared for Spectrum Medsystems Corp. on under FDA product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile). FDA records list one 510(k) clearance for Spectrum Medsystems Corp. As of , FDA records show no recalls naming K961906.

Clearance record

Decision date
Received
(187 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
Spectrum Medsystems Corp. 2166 Michelson Dr., Irvine 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