510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955019Substantially Equivalent

Urotract I

Dornier Medtech America, Inc., Kennesaw GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955019 is the FDA 510(k) clearance record for UROTRACT I, a class I device, cleared for Dornier Medtech America, Inc. on under FDA product code KQS (Table, Cystometric, Non-Electric And Accessories). FDA records list 46 510(k) clearances for Dornier Medtech America, Inc., from to . As of , FDA records show no recalls naming K955019.

Clearance record

Decision date
Received
(34 days to decision)
Product code
KQS Table, Cystometric, Non-Electric And Accessories
Regulation
21 CFR 876.4890
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Dornier Medtech America, Inc. 1155 Roberts Blvd., Kennesaw GA
510(k) summary
Summary
Third party review
No

Clearances, product code KQS

Trailing 12 months

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

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