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ApexMV

by Incontrol Medical, LLC

510(k) K182022

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK182022 Date15 Mar 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KPI
Device class
Class II
Regulation
21 CFR Part 876.5320
Advisory committee
Gastroenterology, Urology
FDA decision
SESK Substantially Equivalent — Kit

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ApexMV is a non-implantable electrical stimulator designed to treat urinary incontinence. Classified as a Class II device under FDA product code KPI, it targets both stress incontinence and overactive bladder conditions by delivering targeted muscle stimulation to the pelvic floor. Its primary function is to strengthen pelvic floor muscles through controlled electrical impulses, aiding in the management of bladder leakage associated with activities such as coughing, laughing, or exercise.

The device is intended for home use and operates via short, 10-minute sessions, typically administered six days per week. Supplied as a reusable medical device, it requires no sterilization between uses. The ApexMV has received FDA 510(k) clearance under the Traditional pathway, with registration numbers including 1718873 and others listed under regulation 876.5320. No MRI safety information or specific size variations are noted in the regulatory data.

Devices cleared under K182022

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K182022
UDI-DISize and differences
Attain 3200000A1
INCONTROL MEDICAL, LLC
3200000A1 / 3200000A100851508007103
Length 4.1 in
On the market

Similar devices

Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

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