510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062061Substantially Equivalent

Urassist

Preferred Medical Devices, Inc., Kittery ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062061 is the FDA 510(k) clearance record for URASSIST, a class I device, cleared for Preferred Medical Devices, Inc. on under FDA product code NZU (Collector, Urine, Powered, Non Indwelling Catheter). FDA's definition for product code NZU reads: "For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair". FDA records list one 510(k) clearance for Preferred Medical Devices, Inc. As of , FDA records show no recalls naming K062061.

Clearance record

Decision date
Received
(77 days to decision)
Product code
NZU Collector, Urine, Powered, Non Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Preferred Medical Devices, Inc. 8 Gray Lodge Rd., Kittery ME
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZU

Trailing 12 months

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

FDA records show no clearances under product code NZU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZU, 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