510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931574Substantially Equivalent

Advance Model Uds-Adv

Abbott Medical, Mississauga, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931574 is the FDA 510(k) clearance record for ADVANCE MODEL UDS-ADV, a class II device, cleared for Laborie Medical Technologies, Ltd. on under FDA product code EXQ (Cystometer, Electrical Recording). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K931574.

Clearance record

Decision date
Received
(128 days to decision)
Product code
EXQ Cystometer, Electrical Recording
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laborie Medical Technologies, Ltd. 6415 Northwest Dr., Unit 11, Mississauga, CA
510(k) summary
Statement
Third party review
No

Clearances, product code EXQ

Trailing 12 months
1 clearance under product code EXQ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EXQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260