Cleared Special

K061288 - AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER

K061288 is an FDA 510(k) clearance for AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 177-day FDA review.

K061288 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
177d
Days
Class 2
Risk

K061288 is an FDA 510(k) clearance for the AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on November 2, 2006 after a review of 177 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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.

View all United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K061288

510(k) Number K061288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2006
Decision Date November 02, 2006
Days to Decision 177 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
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Modification to existing cleared device.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 141
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K061288.
CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
K063644 · Cardica, Inc. · Jan 2007
U-CLIP DEVICE
K062821 · Medtronic Neurosurgery · Dec 2006
C-PORT DISTAL ANASTOMOSIS SYSTEM
K053524 · Cardica, Inc. · Nov 2006
HEM-O-LOK LIGATION CLIP
K062914 · Teleflex Medical · Nov 2006
ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)
K062008 · Niti Medical Technologies , Ltd. · Aug 2006
U-CLIP DEVICE, MODEL NC65
K062057 · Medtronic Vascular · Aug 2006