Cleared Traditional

K895659 - HUI MINI-FLEX

K895659 is the FDA 510(k) clearance for HUI MINI-FLEX by Unimar, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIG) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K895659 · Unimar, Inc. · Obstetrics & Gynecology device
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Dec 1989
Decision
90d
Days
Class 2
Risk

K895659 is an FDA 510(k) clearance for the HUI MINI-FLEX. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Unimar, Inc. (Wilton, US). The FDA issued a Cleared decision on December 19, 1989 after a review of 90 days - within the typical 510(k) review window.

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.

View all Unimar, Inc. devices

Submission Details

510(k) Number K895659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date December 19, 1989
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
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 K895659.
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
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K892001 · Dexide, Inc. · Jun 1989
UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET
K891028 · Zinnanti Surgical Instruments, Inc. · Mar 1989