Cleared Traditional

K000098 - SOFTLINE SPRING CLIP

K000098 is an FDA 510(k) clearance for SOFTLINE SPRING CLIP, 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 90-day FDA review.

K000098 · Novare Surgical Systems, Inc. · Cardiovascular device
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Apr 2000
Decision
90d
Days
Class 2
Risk

K000098 is an FDA 510(k) clearance for the SOFTLINE SPRING CLIP. 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 April 12, 2000 after a review of 90 days - within the typical 510(k) review window.

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.

View all Novare Surgical Systems, Inc. devices

FDA 510(k) Submission Details - K000098

510(k) Number K000098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2000
Decision Date April 12, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 111
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K000098.
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001
ENGAGE JAW INSERTS
K992980 · Novare Surgical Systems, Inc. · Jun 2000
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992174 · Pilling Weck Surgical · Mar 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
SLIMLINE SURGICAL CLAMP
K992640 · Minumys Surgical, Inc. · Sep 1999