Cleared Traditional

K936231 - THE KARL STORZ HAMOU ENDOMAT

K936231 is an FDA 510(k) clearance for THE KARL STORZ HAMOU ENDOMAT, manufactured by Karl Storz Endoscopy. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K936231 · Karl Storz Endoscopy · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 1995
Decision
391d
Days
Class 2
Risk

K936231 is an FDA 510(k) clearance for the THE KARL STORZ HAMOU ENDOMAT. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 391 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 Karl Storz Endoscopy devices

FDA 510(k) Submission Details - K936231

510(k) Number K936231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date January 24, 1995
Days to Decision 391 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
231d slower than avg
Panel avg: 160d · This submission: 391d
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 42
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K936231.
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
K950961 · KARL STORZ Endoscopy-America, Inc. · May 1995
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
K941743 · Cabot Medical Corp. · Apr 1995
HYS-SURGIFLATOR
K924523 · W.O.M. World of Medicine GmbH · Apr 1995
BARD HYSTERO-FLO II PUMP
K933384 · Davol Inc., Sub. C. R. Bard, Inc. · Dec 1994
CONCEPT UNIVERSAL PUMP SYSTEM
K933873 · Linvatec Corp. · Dec 1994
HYSTEROMED 100
K930912 · Northgate Technologies, Inc. · Oct 1994