Cleared Traditional

K941743 - CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941743 · Cabot Medical Corp. · Obstetrics & Gynecology device
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Apr 1995
Decision
377d
Days
Class 2
Risk

K941743 is an FDA 510(k) clearance for the CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Cabot Medical Corp. (Langhorne, US). The FDA issued a Cleared decision on April 19, 1995 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - the FDA obstetrics and gynecology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cabot Medical Corp. devices

Submission Details

510(k) Number K941743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1994
Decision Date April 19, 1995
Days to Decision 377 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 160d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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 Obstetrics & Gynecology devices follow this clearance model.