Cleared Traditional

K810569 - CONTACT-MICRO COLPOHYSTEROSCOPE (FDA 510(k) Clearance)

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

K810569 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
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Jul 1981
Decision
135d
Days
Class 2
Risk

K810569 is an FDA 510(k) clearance for the CONTACT-MICRO COLPOHYSTEROSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 135 days - within the typical 510(k) review window.

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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K810569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date July 16, 1981
Days to Decision 135 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
25d faster than avg
Panel avg: 160d · This submission: 135d
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 168
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K810569.
InnovexView (GC146-17, GC150-20, GC155-23)
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K252793 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Dec 2025
SPY Cystoscope/Hysteroscope
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RZ Resectoscope System
K243382 · Rz Medizintechnik GmbH · Jun 2025
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
K240978 · MacroLux Medical Technology Co., Ltd. · Aug 2024
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241987 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Aug 2024