Cleared Special

K142547 - Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm

K142547 is an FDA 510(k) clearance for Bluntport Blunt Trocar with Threaded An..., 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 90-day FDA review.

K142547 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
90d
Days
Class 2
Risk

K142547 is an FDA 510(k) clearance for the Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm. 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 December 9, 2014 after a review of 90 days - within the typical 510(k) review window.

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 - K142547

510(k) Number K142547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2014
Decision Date December 09, 2014
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K142547.
Percuvance(R) Percutaneous Surgical System
K143299 · Teleflexmedical, Inc. · Jan 2015
TISSUE CONTAINMENT SYSTEM
K142427 · Applied Medical Resources · Dec 2014
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
K140593 · Cook, Inc. · Dec 2014
Schoelly Laparoscope
K143221 · Schoelly Fiberoptic GmbH · Dec 2014
Surgisleeve Wound Protector
K143091 · Covidien, LLC · Nov 2014
UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
K141593 · Unimicro Medical Systems (Shenzhen) Co., Ltd. · Nov 2014
K142547 · Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
Download PDF FDA Summary Covidien