Cleared Special

K112349 - VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR

K112349 is an FDA 510(k) clearance for VERSAPORT V2 BLADELESS OPTIICAL TROCAR ..., manufactured by Covidien, Formerly US Surgical A Divison of Tyco H. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 16-day FDA review.

K112349 · Covidien, Formerly US Surgical A Divison of Tyco H · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
16d
Days
Class 2
Risk

K112349 is an FDA 510(k) clearance for the VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Covidien, Formerly US Surgical A Divison of Tyco H (North Haven, US). The FDA issued a Cleared decision on September 1, 2011 after a review of 16 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 - K112349

510(k) Number K112349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2011
Decision Date September 01, 2011
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 K112349.
UNIMAX TROCAR SYSTEM
K112358 · Unimax Medical Systems, Inc. · Oct 2011
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
K112456 · Teleflexmedical, Inc. · Oct 2011
THE ESPINER SAC OR E SAC
K111845 · Espiner Medical Limited · Sep 2011
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
K101733 · Sac, LLC Dba Pinnacle Medical Surgical · Jun 2011
UNIMAX SUCTION IRRIGATION SET
K103509 · Unimax Medical Systems, Inc. · May 2011
WEXLER ENDOSCOPE ACCESSORIES
K110121 · Microsurgical Laboratories,Inc.Dba Wexler Surgical · May 2011