Cleared Traditional

K912498 - THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR

K912498 is an FDA 510(k) clearance for THE KARL STORZ 26025UC HAMOU ELEC HYSTE..., manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K912498 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
196d
Days
Class 2
Risk

K912498 is an FDA 510(k) clearance for the THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 196 days - an extended review cycle.

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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K912498

510(k) Number K912498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1991
Decision Date December 18, 1991
Days to Decision 196 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
35d slower than avg
Panel avg: 161d · This submission: 196d
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 56
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K912498.
WOM HYSTEROFLATOR OP
K922632 · W.O.M. GmbH · Mar 1994
7-510-25 HYSTEROMED TUBING KIT
K931606 · Nortech · Jan 1994
INSUFFLATOR TUBING KIT
K922197 · O.R. Concepts, Inc. · Sep 1993
HYSTEROFLATOR 1500
K911844 · F.M. Wiest USA, Inc. · Nov 1991
LM-100/200LOW FLOW INSUFFLATOR
K912789 · Leisegang Medical, Inc. · Sep 1991
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
K905495 · Frigitronics, Inc. · Apr 1991
K912498 · THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
Download PDF FDA Summary KARL STORZ Endoscopy-…