Cleared Traditional

K993411 - FEMISCAN CLINIC SYSTEM

K993411 is the FDA 510(k) clearance for FEMISCAN CLINIC SYSTEM by Mega Electronics , Ltd.. It is a Class 2 Gastroenterology & Urology device (product code HIR) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993411 · Mega Electronics , Ltd. · Gastroenterology & Urology device
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Jan 2000
Decision
90d
Days
Class 2
Risk

K993411 is an FDA 510(k) clearance for the FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS.... Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Mega Electronics , Ltd. (East Longmeadow, US). The FDA issued a Cleared decision on January 10, 2000 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 884.1425 - 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 Mega Electronics , Ltd. devices

Submission Details

510(k) Number K993411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date January 10, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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 - HIR Perineometer

All 18
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K993411.
leva Pelvic Floor Trainer
K180637 · Renovia, Inc. · Apr 2018
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · Hollister, Inc. · Mar 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653 · Hollister, Inc. · Mar 2002
PERINEOMETER
K960311 · Hollister, Inc. · Apr 1996
CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI
K891774 · Hollister, Inc. · Aug 1989