510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K922562Substantially Equivalent

Stimtech Pfx, Catalog Number 78-8540

Stimtech Products, Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922562 is the FDA 510(k) clearance record for STIMTECH PFX, CATALOG NUMBER 78-8540, a class II device, cleared for Stimtech Products on under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence). FDA records list 3 510(k) clearances for Stimtech Products, from to . As of , FDA records show no recalls naming K922562.

Clearance record

Decision date
Received
(499 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
Stimtech Products One Brigham St., Marlborough MA
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 October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20262
May 20262
June 20261
July 20260
August 20260
September 20261
October 20260