Cleared Traditional

OLYMPUS HYSTERORESECTOSCOPE (K897003) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K897003 · Olympus Corp. · Obstetrics & Gynecology device
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Mar 1990
Decision
88d
Days
Class 2
Risk

K897003 is an FDA 510(k) clearance for the OLYMPUS HYSTERORESECTOSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on March 16, 1990 after a review of 88 days - a notably fast clearance 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: 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 Olympus Corp. devices

Submission Details

510(k) Number K897003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date March 16, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 85
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K897003.
RESECTOSCOPE SHEATH
K931994 · Olympus Corp. · Feb 1994
HYSTEROSCOPY SHEATH SET
K903146 · Cook, Inc. · Oct 1990
CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY
K895857 · Richard Wolf Medical Instruments Corp. · Jun 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