Cleared Traditional

K010785 - KSEA DION-GRACIA SET

K010785 is an FDA 510(k) clearance for KSEA DION-GRACIA SET, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K010785 · KARL STORZ Endoscopy-America, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
159d
Days
Class 2
Risk

K010785 is an FDA 510(k) clearance for the KSEA DION-GRACIA SET. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 21, 2001 after a review of 159 days - an extended review cycle.

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. Standard predicate reliance. 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 - K010785

510(k) Number K010785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2001
Decision Date August 21, 2001
Days to Decision 159 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
34d slower than avg
Panel avg: 125d · This submission: 159d
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 204
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K010785.
THE HAMMER MODEL H100
K012041 · Tenacore Holdings, Inc. · Mar 2002
VCS-A SERIES CLAMP
K011863 · Vascular Control Systems, Inc. · Feb 2002
INCLUDER CLAMP
K010694 · Novare Surgical Systems, Inc. · Feb 2002
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001
GUIDANT AXIUS CORONARY SHUNT
K010117 · Cardiothoracic Systems, Inc. · Apr 2001
FLEXIBLE OCCLUSION SYSTEM
K002915 · Applied Medical · Jan 2001
K010785 · KSEA DION-GRACIA SET
Download PDF FDA Summary KARL STORZ Endoscopy-…