Cleared Traditional

AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES (K962807) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962807 · American Surgical Sponges · Neurology device
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Optimized for regulatory review, auditing and printing
May 1997
Decision
288d
Days
Class 2
Risk

K962807 is an FDA 510(k) clearance for the AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by American Surgical Sponges (Great Neck, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 288 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - 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 American Surgical Sponges devices

Submission Details

510(k) Number K962807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date May 02, 1997
Days to Decision 288 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
140d slower than avg
Panel avg: 148d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
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.