Cleared Traditional

K163654 - VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar

K163654 is an FDA 510(k) clearance for VersaOne fascial closure system bladed ..., manufactured by Covidien, LLC. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K163654 · Covidien, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
75d
Days
Class 2
Risk

K163654 is an FDA 510(k) clearance for the VersaOne fascial closure system bladed trocar, VersaOne fascial closure syste.... Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on March 8, 2017 after a review of 75 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Covidien, LLC devices

FDA 510(k) Submission Details - K163654

510(k) Number K163654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date March 08, 2017
Days to Decision 75 days
Submission Type Traditional
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
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1293
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K163654.
FUJIFILM Surgical System
K162836 · Fujifilm New Development U.S.A., Inc. · Mar 2017
NOVATECH TALCAIR
K170030 · Novatech SA · Mar 2017
InterLock Trocar
K170084 · Fujifilm New Development U.S.A., Inc. · Mar 2017
Laparoscope Lens Shield Device (LENS)
K170103 · Medeon Biodesign, Inc. · Feb 2017
EndoClot
K162197 · Endoclot Plus Co., Ltd. · Jan 2017
U-IGNITE Bladeless Trocar
K162387 · Tianjin Uwell Medical Device Manufacturing Co., Ltd. · Jan 2017