510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971913Substantially Equivalent

Gr100f Urine Flowmeter

Albyn Medical, Ltd., Dingwall, Ross-Shire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971913 is the FDA 510(k) clearance record for GR100F URINE FLOWMETER, a class II device, cleared for Albyn Medical , Ltd. on under FDA product code EXY (Uroflowmeter). FDA records list one 510(k) clearance for Albyn Medical , Ltd. As of , FDA records show no recalls naming K971913.

Clearance record

Decision date
Received
(120 days to decision)
Product code
EXY Uroflowmeter
Regulation
21 CFR 876.1800
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Albyn Medical , Ltd. Bridgend Rd. Ind'L Estate, Dingwall, Ross-Shire, GB
510(k) summary
Summary
Third party review
No

Clearances, product code EXY

Trailing 12 months

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

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