Cleared Traditional

K010694 - INCLUDER CLAMP

K010694 is an FDA 510(k) clearance for INCLUDER CLAMP, manufactured by Novare Surgical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K010694 · Novare Surgical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
340d
Days
Class 2
Risk

K010694 is an FDA 510(k) clearance for the INCLUDER CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Novare Surgical Systems, Inc. (Cupertino, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K010694

510(k) Number K010694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2001
Decision Date February 11, 2002
Days to Decision 340 days
Submission Type Traditional
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
215d slower than avg
Panel avg: 125d · This submission: 340d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K010694.
FLEXLINE CLAMP
K010727 · Novare Surgical Systems, Inc. · Aug 2002
THE HAMMER MODEL H100
K012041 · Tenacore Holdings, Inc. · Mar 2002
VCS-A SERIES CLAMP
K011863 · Vascular Control Systems, Inc. · Feb 2002
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001
GUIDANT AXIUS CORONARY SHUNT
K010117 · Cardiothoracic Systems, Inc. · Apr 2001
K010694 · INCLUDER CLAMP
Download PDF FDA Summary Novare Surgical Syste…