Cleared Special

K020470 - MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE

K020470 is an FDA 510(k) clearance for MODIFICATION TO CORLINK AUTOMATED ANAST..., manufactured by Bypass , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 24-day FDA review.

K020470 · Bypass , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
24d
Days
Class 2
Risk

K020470 is an FDA 510(k) clearance for the MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Bypass , Ltd. (Washington, US). The FDA issued a Cleared decision on March 8, 2002 after a review of 24 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.

View all Bypass , Ltd. devices

FDA 510(k) Submission Details - K020470

510(k) Number K020470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2002
Decision Date March 08, 2002
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
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 127
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K020470.
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · Vanguard Medical Concepts, Inc. · Dec 2003
MODIFICATION TO SUTURE CLINCH
K033024 · Applied Medical Resources Corp. · Oct 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · Advanced Surgical Products, Inc. · Jul 2003
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · American Medical Systems, Inc. · Sep 2001
BIOPSY SITE MARKER
K011402 · Senorx, Inc. · Jul 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236 · Applied Medical Resources Corp. · May 2001