Cleared Traditional

K100280 - GYNCARE MORCELLEX TISSUE MORCELLATOR

K100280 is the FDA 510(k) clearance for GYNCARE MORCELLEX TISSUE MORCELLATOR by Ethicon, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K100280 · Ethicon, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
51d
Days
Class 2
Risk

K100280 is an FDA 510(k) clearance for the GYNCARE MORCELLEX TISSUE MORCELLATOR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 24, 2010 after a review of 51 days - a notably fast clearance cycle.

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: 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 Ethicon, Inc. devices

Submission Details

510(k) Number K100280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2010
Decision Date March 24, 2010
Days to Decision 51 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 160d · This submission: 51d
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 137
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K100280.
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
K123365 · Olympus Medical Systems Corp. · Mar 2013
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
K111425 · Olympus Medical Systems Corp. · Apr 2012
ENDOEYE HD II
K111788 · Olympus America, Inc. · Jan 2012
ENDOSCOPIC CO2 REGULATION UNIT UCR
K081173 · Olympus Medical Systems Corporation · Dec 2008
STRYKER VIDEOSCOPE
K082451 · Stryker Endoscopy · Dec 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K080948 · Olympus Medical Systems Corporation · Sep 2008