Cleared Special

K160230 - VersaOne Optical Trocar 15mm

K160230 is the FDA 510(k) clearance for VersaOne Optical Trocar 15mm by Covidien. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K160230 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
29d
Days
Class 2
Risk

K160230 is an FDA 510(k) clearance for the VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm. 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 March 1, 2016 after a review of 29 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.

View all Covidien devices

Submission Details

510(k) Number K160230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2016
Decision Date March 01, 2016
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 508
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K160230.
AdTec
K160393 · Aesculap, Inc. · May 2016
Stryker SDC3 HD Information Management System with Wireless Device Control Capability
K160332 · Stryker Endoscopy · May 2016
True HD 3MOS Camera System
K161017 · Conmed Corporation · May 2016
Arthrex Synergy UHD4 System
K153218 · Arthrex, Inc. · Feb 2016
VersaOne Bladed Trocar 5mm
K152149 · Covidien · Jan 2016
da Vinci Xi Hasson Cone
K153126 · Intuitive Surgical, Inc. · Dec 2015