Cleared Traditional

K000212 - KSEA CHARDONNES MORCELLATION KNIFE (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K000212 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
88d
Days
Class 1
Risk

K000212 is an FDA 510(k) clearance for the KSEA CHARDONNES MORCELLATION KNIFE. Classified as Instrument, Manual, General Obstetric-gynecologic (product code KOH), Class I - General Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 21, 2000 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 884.4520 - 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K000212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2000
Decision Date April 21, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOH Instrument, Manual, General Obstetric-gynecologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.