Cleared Special

K050639 - LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM

K050639 is an FDA 510(k) clearance for LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM, manufactured by Lumenis, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code GCJ cleared through the Special 510(k) pathway after a 17-day FDA review.

K050639 · Lumenis, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
17d
Days
Class 2
Risk

K050639 is an FDA 510(k) clearance for the LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Lumenis, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 31, 2005 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 876.1500 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lumenis, Inc. devices

FDA 510(k) Submission Details - K050639

510(k) Number K050639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2005
Decision Date March 31, 2005
Days to Decision 17 days
Submission Type Special
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
143d faster than avg
Panel avg: 160d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GCJ Laparoscope, General & Plastic Surgery

All 801
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K050639.
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
K050209 · Smith & Nephew, Inc. · Nov 2005
ENDOSCOPIC APPLICATOR
K051732 · Ethicon, Inc. · Aug 2005
ARMAND ENDOSCOPE HOLDER
K050051 · KLS-Martin L.P. · May 2005
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
K042834 · Micromedics, Inc. · Feb 2005
MODIFIED SPACEMAKER SYSTEM
K042412 · United States Surgical, A Division of Tyco Healthc · Sep 2004
MODIFICATION TO OPTICAL SEPARATOR SYSTEM
K041795 · Applied Medical Resources Corp. · Sep 2004