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FDA 510(k)

ULTRACELL NEURO SPONGES

K-Number: K970328 · 1997-04-21

ApplicantUltracell Medical Technologies, Inc.
Decision Date1997-04-21
Product CodeHBA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTRACELL NEURO SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Ultracell Medical Technologies, Inc.. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K970328. The device is classified under product code HBA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACELL NEURO SPONGES?

ULTRACELL NEURO SPONGES is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Ultracell Medical Technologies, Inc.. The 510(k) number is K970328.

When did ULTRACELL NEURO SPONGES receive FDA 510(k) clearance?

ULTRACELL NEURO SPONGES received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970328.

Who is the listed applicant for ULTRACELL NEURO SPONGES?

The FDA 510(k) record lists Ultracell Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRACELL NEURO SPONGES?

The FDA product code for ULTRACELL NEURO SPONGES is HBA.

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Other records listing Ultracell Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012196ULTRACELL ABSORBENT STICKK972633ULTRACELL SUCTION SPONGEK972634ULTRACELL SUCTION SPONGEK973083ULTRACELL NEURO SPONGESK973558VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)K973085ULTRACELL PACKING WITH SLEEVE

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Related Devices (Code: HBA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193346Codman Surgical Patties & StripsIntegra LifeSciences CorporationK112598AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)American Surgical Company, LLCK121822DELICOTAmerican Surgical Company, LLCK073576NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGESHarod Enterprises, Inc.K062406AESCULAP NEURO PATTIESAesculap, Inc.K031008AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)Aesculap

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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