Cleared Traditional

K905495 - HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR

K905495 is an FDA 510(k) clearance for HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC ..., manufactured by Frigitronics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K905495 · Frigitronics, Inc. · Obstetrics & Gynecology device
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Apr 1991
Decision
143d
Days
Class 2
Risk

K905495 is an FDA 510(k) clearance for the HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Frigitronics, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 143 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 Frigitronics, Inc. devices

FDA 510(k) Submission Details - K905495

510(k) Number K905495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date April 29, 1991
Days to Decision 143 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
17d faster than avg
Panel avg: 160d · This submission: 143d
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 43
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K905495.
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