Cleared Traditional

K891774 - CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI

K891774 is an FDA 510(k) clearance for CONTIMED II BIOFEEDBACK DEV TREAT OF UR..., manufactured by Hollister, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K891774 · Hollister, Inc. · Gastroenterology & Urology device
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Aug 1989
Decision
152d
Days
Class 2
Risk

K891774 is an FDA 510(k) clearance for the CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI. Classified as Perineometer (product code HIR), 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 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K891774

510(k) Number K891774 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
21d slower than avg
Panel avg: 131d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIR Device Classification - Class 2, Special Controls

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.