Cleared Traditional

K992980 - ENGAGE JAW INSERTS

K992980 is an FDA 510(k) clearance for ENGAGE JAW INSERTS, 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 279-day FDA review.

K992980 · Novare Surgical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
279d
Days
Class 2
Risk

K992980 is an FDA 510(k) clearance for the ENGAGE JAW INSERTS. 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 June 8, 2000 after a review of 279 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 - K992980

510(k) Number K992980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1999
Decision Date June 08, 2000
Days to Decision 279 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
154d slower than avg
Panel avg: 125d · This submission: 279d
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 K992980.
GUIDANT AXIUS CORONARY SHUNT
K010117 · Cardiothoracic Systems, Inc. · Apr 2001
FLEXIBLE OCCLUSION SYSTEM
K002915 · Applied Medical · Jan 2001
COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
K002767 · Semler Technologies, Inc. · Sep 2000
SOFTLINE SPRING CLIP
K000098 · Novare Surgical Systems, Inc. · Apr 2000
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992174 · Pilling Weck Surgical · Mar 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
K992980 · ENGAGE JAW INSERTS
Download PDF FDA Summary Novare Surgical Syste…