510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K891007Substantially Equivalent

Nonimplanted Electrical Continence Device

Tridak Division of Indicon, Inc., Williston VT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891007 is the FDA 510(k) clearance record for NONIMPLANTED ELECTRICAL CONTINENCE DEVICE, a class II device, cleared for Tridak Division of Indicon, Inc. on under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence). FDA records list 7 510(k) clearances for Tridak Division of Indicon, Inc., from to . As of , FDA records show no recalls naming K891007.

Clearance record

Decision date
Received
(465 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
Tridak Division of Indicon, Inc. 20 Commerce St. Unit 2, Williston VT
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