Microgyn Plus Stimulation Device

Q: What is the product code of K013141?

The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.

FDA 510(k) K013141 · Hollister, Inc.

Substantially Equivalent

510(k) numberK013141

Submission

Device name: Microgyn Plus Stimulation Device
Applicant: Hollister, Inc.
Libertyville, IL, US
Received: September 20, 2001
Decision date: December 19, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KPI – Stimulator, Electrical, Non-Implantable, For Incontinence
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5320
Specialty: Gastroenterology, Urology

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K252334	PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)KPI · Traditional	Pontemedag	04/17/2026SE
K251760	Well-Life Incontinence Stimulation System (WL-2405i(P))KPI · Traditional	Well-Life Healthcare , Ltd.	02/12/2026SE
K251026	Regenesis EMS ChairKPI · Traditional	Trinity Medical Solutions	08/29/2025SE
K243079	NeuroTrac® MyoPlus Pro (MYO120U)KPI · Traditional	Verity Medical , Ltd.	06/26/2025SE
K241862	Levina Pelvic Floor Muscle Stimulator (RS-48)KPI · Traditional	Zmi Electronics , Ltd.	03/27/2025SE
K241516	BTL-398KPI · Traditional	BTL Industries, Inc.	02/10/2025SE

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Questions and answers

When was Microgyn Plus Stimulation Device cleared by the FDA?

Microgyn Plus Stimulation Device (K013141) received a 510(k) decision of Substantially Equivalent on December 19, 2001, 90 days after the submission was received.

What is the product code of K013141?

The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.