Cleared Traditional

K950647 - ULTRACELL NEURO SPONGES

K950647 is an FDA 510(k) clearance for ULTRACELL NEURO SPONGES, manufactured by Ultracell Medical Technologies, Inc.. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K950647 · Ultracell Medical Technologies, Inc. · Neurology device
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Aug 1995
Decision
183d
Days
Class 2
Risk

K950647 is an FDA 510(k) clearance for the ULTRACELL NEURO SPONGES. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by Ultracell Medical Technologies, Inc. (Old Mystic, US). The FDA issued a Cleared decision on August 15, 1995 after a review of 183 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 Ultracell Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K950647

510(k) Number K950647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date August 15, 1995
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
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. No clinical trials required.

HBA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HBA Neurosurgical Paddie

Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K950647.
Codman Surgical Patties & Strips
K193346 · Integra LifeSciences Corporation · Nov 2020
MEDLINE NEURO SPONGE
K140369 · Medline Industries, Inc. · Sep 2014
AESCULAP NEURO PATTIES
K062406 · Aesculap, Inc. · Sep 2006
NEUROLOGICAL SPONGE
K914600 · I M, Inc. · Dec 1992
CODMAN SURGICAL PATTIE
K880402 · Codman & Shurtleff, Inc. · Mar 1988