Cleared Special

K151548 - VersaOne Bladed Trocar, VersaOne Bladeless Trocar

K151548 is an FDA 510(k) clearance for VersaOne Bladed Trocar, manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 23-day FDA review.

K151548 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
23d
Days
Class 2
Risk

K151548 is an FDA 510(k) clearance for the VersaOne Bladed Trocar, VersaOne Bladeless Trocar. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on July 2, 2015 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K151548

510(k) Number K151548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2015
Decision Date July 02, 2015
Days to Decision 23 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1400
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K151548.
Laparoscope Lens Shield Device
K151117 · Medeon Biodesign, Inc. · Aug 2015
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
K141594 · Unimicro Medical Systems (Shenzhen) Co., Ltd. · Aug 2015
Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
K150377 · Sony Electronics, Inc. · Jul 2015
Tissue Removal Pouch
K150781 · Boehringer Laboratories, LLC · Jun 2015
Spacemaker Pro Access and Dissector System
K151356 · Covidien, LLC · Jun 2015
LaparoVue
K150569 · Buffalo Filter, LLC · Jun 2015
K151548 · VersaOne Bladed Trocar, VersaOne Bladeless Trocar
Download PDF FDA Summary Covidien