Cleared Traditional

K870399 - SELVERSTONE CLAMP SALIBI CLAMP

K870399 is the FDA 510(k) clearance for SELVERSTONE CLAMP SALIBI CLAMP by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HCE) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K870399 · Codman & Shurtleff, Inc. · Neurology device
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Mar 1987
Decision
32d
Days
Class 2
Risk

K870399 is an FDA 510(k) clearance for the SELVERSTONE CLAMP SALIBI CLAMP. Classified as Clamp, Carotid Artery (product code HCE), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on March 6, 1987 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5175 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K870399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1987
Decision Date March 06, 1987
Days to Decision 32 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 148d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCE Clamp, Carotid Artery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5175
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 Neurology devices follow this clearance model.