Cleared Traditional

K912789 - LM-100/200LOW FLOW INSUFFLATOR

K912789 is the FDA 510(k) clearance for LM-100/200LOW FLOW INSUFFLATOR by Leisegang Medical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIG) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K912789 · Leisegang Medical, Inc. · Obstetrics & Gynecology device
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Sep 1991
Decision
87d
Days
Class 2
Risk

K912789 is an FDA 510(k) clearance for the LM-100/200LOW FLOW INSUFFLATOR. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Leisegang Medical, Inc. (Boca Raton, US). The FDA issued a Cleared decision on September 20, 1991 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Leisegang Medical, Inc. devices

Submission Details

510(k) Number K912789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date September 20, 1991
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
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.

Regulatory Peers - HIG Insufflator, Hysteroscopic

All 28
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K912789.
HYSTEROMED 100
K930912 · Northgate Technologies, Inc. · Oct 1994
INSUFFLATOR TUBING KIT
K922197 · O.R. Concepts, Inc. · Sep 1993
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
K912498 · KARL STORZ Endoscopy-America, Inc. · Dec 1991
DAVOL SCOPE IRRIGATION SYSTEM
K901288 · C.R. Bard, Inc. · Oct 1990
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908 · Zimmer, Inc. · May 1990
HYSTEROFLATOR 2001
K895907 · Cabot Medical Corp. · Dec 1989