Cleared Special

K152565 - Auto Suture Locking Trocar

K152565 is an FDA 510(k) clearance for Auto Suture Locking Trocar, 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 30-day FDA review.

K152565 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
30d
Days
Class 2
Risk

K152565 is an FDA 510(k) clearance for the Auto Suture Locking Trocar. 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 October 9, 2015 after a review of 30 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 - K152565

510(k) Number K152565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2015
Decision Date October 09, 2015
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 K152565.
ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
K151609 · Nds Surgical Imaging, LLC · Nov 2015
Retrieval bag system
K151489 · Beacon Surgical, Inc. · Oct 2015
Bladeless Optical Obturators
K152663 · Intuitive Surgical, Inc. · Oct 2015
KSEA CMOS Camera System (C-cam)
K143640 · KARL STORZ Endoscopy-America, Inc. · Sep 2015
Tissue Removal System
K151990 · Boehringer Laboratories, LLC · Sep 2015
ab medica irrigation/suction gravity system
K151822 · Ab Medica Sas · Sep 2015
K152565 · Auto Suture Locking Trocar
Download PDF FDA Summary Covidien