Cleared Traditional

K971541 - VAGINAL 2 ELECTRODE STIMULATION/EMG PRO...

K971541 is an FDA 510(k) clearance for VAGINAL 2 ELECTRODE STIMULATION/EMG PRO..., 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 58-day FDA review.

K971541 · Hollister, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
58d
Days
Class 2
Risk

K971541 is an FDA 510(k) clearance for the VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON. 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 June 25, 1997 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hollister, Inc. devices

FDA 510(k) Submission Details - K971541

510(k) Number K971541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date June 25, 1997
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
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 K971541.
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K974048 · Hollister, Inc. · Dec 1997
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
K972054 · Empi · Aug 1997
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
K971527 · Empi · Jun 1997
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
K970077 · Utah Medical Products, Inc. · May 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
K970307 · Empi · Apr 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
K970602 · Hollister, Inc. · Apr 1997