Cleared Traditional

K891773 - MICROGYN II ELEC STIM DEVICE TREAT OF U...

K891773 is an FDA 510(k) clearance for MICROGYN II ELEC STIM DEVICE TREAT OF U..., 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 152-day FDA review.

K891773 · Hollister, Inc. · Gastroenterology & Urology device
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Aug 1989
Decision
152d
Days
Class 2
Risk

K891773 is an FDA 510(k) clearance for the MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI. 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 August 23, 1989 after a review of 152 days - an extended review 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: 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 - K891773

510(k) Number K891773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date August 23, 1989
Days to Decision 152 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 130d · This submission: 152d
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 K891773.
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K874867 · Bentley Laboratories, Inc. · Feb 1988
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K761145 · G.D. Searle and Co. · Dec 1976