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
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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
40d faster than avg
Panel avg: 130d · 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 53
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K013141.
HPM-6000U
K162010 · BTL Industries, Inc. · Dec 2016
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
K122194 · Everyway Medical Instruments Co.,Ltd · Apr 2013
EVADRI BLADDER CONTROL SYSTEMS
K050483 · Hollister, Inc. · Apr 2005
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
K990456 · Hollister, Inc. · Mar 1999
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · Empi · Nov 1998
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K974048 · Hollister, Inc. · Dec 1997