Cleared Traditional

K071406 - AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER

K071406 is an FDA 510(k) clearance for AUTOSUTURE 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 Traditional 510(k) pathway after a 184-day FDA review.

K071406 · 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 2007
Decision
184d
Days
Class 2
Risk

K071406 is an FDA 510(k) clearance for the AUTOSUTURE 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 21, 2007 after a review of 184 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K071406

510(k) Number K071406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date November 21, 2007
Days to Decision 184 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
69d slower than avg
Panel avg: 115d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 157
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K071406.
AESCULAP ENDOSCOPIC CLIP SYTEM
K080753 · Aesculap, Inc. · Apr 2008
CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
K073304 · Cardica, Inc. · Dec 2007
CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150
K073123 · Cardica, Inc. · Dec 2007
ZIPKNOT, MODEL 1017-3000
K072525 · Medicinelodge, Inc. · Oct 2007
C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM
K070548 · Cardica, Inc. · Mar 2007
CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
K063644 · Cardica, Inc. · Jan 2007