Cleared Traditional

K102101 - SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA

K102101 is an FDA 510(k) clearance for SURGIVISION MR COMPATIBLE VENTRICULAR C..., manufactured by Surgivision, Inc.. The device is a Class 1 Neurology device with product code HCD cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K102101 · Surgivision, Inc. · Neurology device
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Jan 2011
Decision
183d
Days
Class 1
Risk

K102101 is an FDA 510(k) clearance for the SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA. Classified as Cannula, Ventricular (product code HCD), Class I - General Controls.

Submitted by Surgivision, Inc. (Irvine, US). The FDA issued a Cleared decision on January 26, 2011 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4060 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgivision, Inc. devices

FDA 510(k) Submission Details - K102101

510(k) Number K102101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2010
Decision Date January 26, 2011
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

HCD Device Classification - Class 1, General Controls

Product Code HCD Cannula, Ventricular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4060
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.