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Apex

by Incontrol Medical, LLC

510(k) K141158

Apex is a Class II device made by Incontrol Medical, LLC, cleared under FDA 510(k) K141158 on 26 Nov 2014, active as of 22 Oct 2026.

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)SESE Substantially Equivalent · Traditional NumberK141158 Date26 Nov 2014ClearedStatusActive

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  • Withdrawn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
SESE Substantially Equivalent

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

Devices cleared under K141158

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 K141158
UDI-DISize and differences
Apex® 3000000A1
INCONTROL MEDICAL, LLC
3000000A1 / 3000000A100851508007028
Length 12 in
On the market

Similar devices

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

Other devices from Incontrol Medical, LLC

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