Cleared Traditional

K013141 - MICROGYN PLUS STIMULATION DEVICE

K013141 is an FDA 510(k) clearance for MICROGYN PLUS STIMULATION DEVICE, manufactured by Hollister, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013141 · Hollister, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
90d
Days
Class 2
Risk

K013141 is an FDA 510(k) clearance for the MICROGYN PLUS STIMULATION DEVICE. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hollister, Inc. devices

FDA 510(k) Submission Details - K013141

510(k) Number K013141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2001
Decision Date December 19, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 87
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K013141.
MYOTRAC INFINITI ELECTRICAL STIMULATOR
K053434 · Thought Technology , Ltd. · Mar 2006
SKYLARK URO PROBE
K053007 · Skylark Device & Systems Co., Ltd. · Dec 2005
EVADRI BLADDER CONTROL SYSTEMS
K050483 · Hollister, Inc. · Apr 2005
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
K011435 · Hmt, Inc. · Jun 2001
K.E.A.T.
K002154 · Emd Electronic Medical Devices, Corp. · Mar 2001
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
K001903 · Neotonus, Inc. · Aug 2000