Cleared Traditional

K810569 - CONTACT-MICRO COLPOHYSTEROSCOPE

K810569 is the FDA 510(k) clearance for CONTACT-MICRO COLPOHYSTEROSCOPE by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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
Combination Product No
PCCP Authorized No
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.