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K Number
K992980
Device Name
ENGAGE JAW INSERTS
Manufacturer
NOVARE SURGICAL SYSTEMS, INC.
Date Cleared
2000-06-08

(279 days)

Product Code
DXC
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For Vascular Work
Suitable for veins and arteries
ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters.
ENGAGE Jaw Inserts are adaptable to Fogarty Hydragrip® Surgical Clamps.

Device Description

ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydra-Grip Surgical Clamps. This surgical clamp is intended for use in vascular surgery.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a 510(k) summary and FDA clearance letter for the Novare Surgical ENGAGE Inserts, establishing its substantial equivalence to predicate devices. It focuses on the device's intended use, classification, and regulatory approval.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the input.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).