Cleared Special

K032589 - ENCLOSE II ANASTOMOSIS ASSIST DEVICE

K032589 is an FDA 510(k) clearance for ENCLOSE II ANASTOMOSIS ASSIST DEVICE, manufactured by Novare Surgical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Special 510(k) pathway after a 14-day FDA review.

K032589 · Novare Surgical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
14d
Days
Class 2
Risk

K032589 is an FDA 510(k) clearance for the ENCLOSE II ANASTOMOSIS ASSIST DEVICE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Novare Surgical Systems, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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 - K032589

510(k) Number K032589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2003
Decision Date September 05, 2003
Days to Decision 14 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 195
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K032589.
PORTACLAMP
K033085 · Cardio Life Research, S.A. · Apr 2004
CSTAT, MODELS 09-0014-01 AND 09-0014-02
K032125 · Vascular Control Systems, Inc. · Feb 2004
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K031812 · Vascular Control Systems, Inc. · Dec 2003
ENCLOSE ANASTOMOSIS ASSIST DEVICE
K023682 · Novare Surgical Systems, Inc. · Jan 2003
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · Radi Medical Systems AB · Dec 2002
VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
K023154 · Vascular Control Systems, Inc. · Dec 2002
K032589 · ENCLOSE II ANASTOMOSIS ASSIST DEVICE
Download PDF FDA Summary Novare Surgical Syste…