Cleared Traditional

K970328 - ULTRACELL NEURO SPONGES

K970328 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 84-day FDA review.

K970328 · Ultracell Medical Technologies, Inc. · Neurology device
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Apr 1997
Decision
84d
Days
Class 2
Risk

K970328 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. (North Stonington, US). The FDA issued a Cleared decision on April 21, 1997 after a review of 84 days - a notably fast clearance 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: 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 Ultracell Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K970328

510(k) Number K970328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1997
Decision Date April 21, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 148d · This submission: 84d
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

All 12
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K970328.
PACIFIC SURGICAL PATTIES
K993019 · V. Mueller Neuro/Spine · Mar 2000
ULTRACELL NEURO SPONGES
K973083 · Ultracell Medical Technologies, Inc. · Dec 1997
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
K962807 · American Surgical Sponges · May 1997
ULTRACELL NEURO SPONGES
K950647 · Ultracell Medical Technologies, Inc. · Aug 1995
NEUROLOGICAL SPONGE
K914600 · I M, Inc. · Dec 1992
CODMAN SURGICAL PATTIE
K880402 · Codman & Shurtleff, Inc. · Mar 1988