Cleared Traditional

K941743 - CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP

K941743 is an FDA 510(k) clearance for CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP, manufactured by Cabot Medical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K941743 · Cabot Medical Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K941743

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
Combination Product No
PCCP Authorized No
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.

HIG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HIG Insufflator, Hysteroscopic

All 37
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K941743.
HYS-SURGIMAT
K934866 · W.O.M. World of Medicine GmbH · Oct 1995
HYS-SURGIFLATOR VP
K933847 · W.O.M. World of Medicine GmbH · Aug 1995
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
K950961 · KARL STORZ Endoscopy-America, Inc. · May 1995
HYS-SURGIFLATOR
K924523 · W.O.M. World of Medicine GmbH · Apr 1995
THE KARL STORZ HAMOU ENDOMAT
K936231 · Karl Storz Endoscopy · Jan 1995
BARD HYSTERO-FLO II PUMP
K933384 · Davol Inc., Sub. C. R. Bard, Inc. · Dec 1994