Cleared Traditional

TROKAMED MORCELLATOR (K091010) - FDA 510(k) Clearance

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

K091010 · Trokamed GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
691d
Days
Class 2
Risk

K091010 is an FDA 510(k) clearance for the TROKAMED MORCELLATOR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Trokamed GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on March 1, 2011 after a review of 691 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Trokamed GmbH devices

Submission Details

510(k) Number K091010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2009
Decision Date March 01, 2011
Days to Decision 691 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
531d slower than avg
Panel avg: 160d · This submission: 691d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 98
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K091010.
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
K150525 · KARL STORZ Endoscopy-America, Inc. · Nov 2015
MORCELLEX SIGMA GENERATOR
K131656 · Ethicon, Inc. · Sep 2013
ENDOEYE HD II
K111788 · Olympus America, Inc. · Jan 2012
GYNCARE MORCELLEX TISSUE MORCELLATOR
K100280 · Ethicon, Inc. · Mar 2010
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
K061050 · Ethicon, Inc. · Jul 2006
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K050404 · Intuitive Surgical, Inc. · Apr 2005