510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K070331Substantially Equivalent

Urostym Biofeedback and Stimulation Device and Accessories

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

K070331 is the FDA 510(k) clearance record for UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES, a class II device, cleared for Laborie Medical Technologies on under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K070331.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation
21 CFR 876.5320
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laborie Medical Technologies 400 Ave. D, Williston VT
510(k) summary
Statement
Third party review
No

Clearances, product code KPI

Trailing 12 months
7 clearances under product code KPI in the twelve months to November 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20262
May 20262
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260