Cleared Special

K152149 - VersaOne Bladed Trocar 5mm

K152149 is an FDA 510(k) clearance for VersaOne Bladed Trocar 5mm, 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 172-day FDA review.

K152149 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
172d
Days
Class 2
Risk

K152149 is an FDA 510(k) clearance for the VersaOne Bladed Trocar 5mm. 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 January 22, 2016 after a review of 172 days - an extended review 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. Standard predicate reliance. 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 - K152149

510(k) Number K152149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2015
Decision Date January 22, 2016
Days to Decision 172 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
57d slower than avg
Panel avg: 115d · This submission: 172d
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 K152149.
VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
K160230 · Covidien · Mar 2016
Arthrex Synergy UHD4 System
K153218 · Arthrex, Inc. · Feb 2016
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
K151036 · Carefusion 2200, Inc. · Feb 2016
General & Plastic Surgery Instruments
K152400 · Sontec Instruments, Inc. · Jan 2016
8X-10-XXXX Camera System
K152513 · Santa Barbara Imaging Systems · Dec 2015
da Vinci Xi Hasson Cone
K153126 · Intuitive Surgical, Inc. · Dec 2015
K152149 · VersaOne Bladed Trocar 5mm
Download PDF FDA Summary Covidien