Cleared Traditional

K892390 - FLEXIBLE IMMERSIBLE HYSTEROSCOPE

K892390 is an FDA 510(k) clearance for FLEXIBLE IMMERSIBLE HYSTEROSCOPE, manufactured by Schott Fiber Optics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K892390 · Schott Fiber Optics, Inc. · Obstetrics & Gynecology device
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Feb 1990
Decision
301d
Days
Class 2
Risk

K892390 is an FDA 510(k) clearance for the FLEXIBLE IMMERSIBLE HYSTEROSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Schott Fiber Optics, Inc. (Southbridge, US). The FDA issued a Cleared decision on February 2, 1990 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Schott Fiber Optics, Inc. devices

FDA 510(k) Submission Details - K892390

510(k) Number K892390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1989
Decision Date February 02, 1990
Days to Decision 301 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
141d slower than avg
Panel avg: 160d · This submission: 301d
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 110
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K892390.
CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY
K895857 · Richard Wolf Medical Instruments Corp. · Jun 1990
OLYMPUS HYSTERORESECTOSCOPE
K897003 · Olympus Corp. · Mar 1990
HYSTEROSCOPE
K896917 · Cabot Medical Corp. · Mar 1990
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
K882270 · KARL STORZ Endoscopy-America, Inc. · Oct 1989
OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE
K891451 · Olympus Corp. · Oct 1989
HYSTEROSCOPE AUTONOM 4992
K880314 · Richard Wolf Medical Instruments Corp. · Aug 1988