Cleared Traditional

K091439 - HEAD FIXATION ARC AND TABLE BASE

K091439 is an FDA 510(k) clearance for HEAD FIXATION ARC AND TABLE BASE, manufactured by Surgivision, Inc.. The device is a Class 2 Radiology device with product code HBL cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K091439 · Surgivision, Inc. · Radiology device
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Aug 2009
Decision
103d
Days
Class 2
Risk

K091439 is an FDA 510(k) clearance for the HEAD FIXATION ARC AND TABLE BASE. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Surgivision, Inc. (Houston, US). The FDA issued a Cleared decision on August 25, 2009 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 882.4460 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgivision, Inc. devices

FDA 510(k) Submission Details - K091439

510(k) Number K091439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2009
Decision Date August 25, 2009
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 Radiology devices follow this clearance model.

Regulatory Peers - HBL Holder, Head, Neurosurgical (skull Clamp)

All 34
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