Cleared Special

K062008 - ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)

K062008 is an FDA 510(k) clearance for ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR), manufactured by Niti Medical Technologies , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 23-day FDA review.

K062008 · Niti Medical Technologies , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
23d
Days
Class 2
Risk

K062008 is an FDA 510(k) clearance for the ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR). Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Niti Medical Technologies , Ltd. (Natanya, IL). The FDA issued a Cleared decision on August 9, 2006 after a review of 23 days - a notably fast clearance 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. 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 - K062008

510(k) Number K062008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2006
Decision Date August 09, 2006
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 176
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K062008.
C-PORT DISTAL ANASTOMOSIS SYSTEM
K053524 · Cardica, Inc. · Nov 2006
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288 · United States Surgical, A Division of Tyco Healthc · Nov 2006
HEM-O-LOK LIGATION CLIP
K062914 · Teleflex Medical · Nov 2006
U-CLIP DEVICE, MODEL NC65
K062057 · Medtronic Vascular · Aug 2006
NEXUS LIGATING CLIP
K053255 · Microsurgical Laboratories,Inc.Dba Wexler Surgical · Mar 2006
U-CLIP DEVICE, MODELS B140, B160 AND B180
K053252 · Medtronic Vascular · Dec 2005
K062008 · ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)
Download PDF FDA Summary Niti Medical Technolo…