Cleared Traditional

K905392 - HT4-SERIES HYSTEROSCOPES AND ACCESSORIES

K905392 is an FDA 510(k) clearance for HT4-SERIES HYSTEROSCOPES AND ACCESSORIES, manufactured by Frigitronics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K905392 · Frigitronics, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 1991
Decision
151d
Days
Class 2
Risk

K905392 is an FDA 510(k) clearance for the HT4-SERIES HYSTEROSCOPES AND ACCESSORIES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Frigitronics, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 30, 1991 after a review of 151 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - 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 - K905392

510(k) Number K905392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1990
Decision Date April 30, 1991
Days to Decision 151 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
9d faster than avg
Panel avg: 160d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIH Device Classification - Class 2, Special Controls

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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 - HIH Hysteroscope (and Accessories)

All 147
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K905392.
CABOT MEDICAL UTERINE RESECTOSCOPE
K924631 · Cabot Medical Corp. · May 1994
RESECTOSCOPE SHEATH
K931994 · Olympus Corp. · Feb 1994
RG27-SERIES RESECTOSCOPE AND ACCESSORIES
K914108 · CooperSurgical, Inc. · Mar 1992
HYSTEROSCOPY SHEATH SET
K903146 · Cook, Inc. · Oct 1990
CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY
K895857 · Richard Wolf Medical Instruments Corp. · Jun 1990
OLYMPUS HYSTERORESECTOSCOPE
K897003 · Olympus Corp. · Mar 1990