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FDA 510(k)

VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)

K-Number: K973558 · 1997-11-24

ApplicantUltracell Medical Technologies, Inc.
Decision Date1997-11-24
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) 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 1997-11-24 under 510(k) number K973558. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)?

VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Ultracell Medical Technologies, Inc.. The 510(k) number is K973558.

When did VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) receive FDA 510(k) clearance?

VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973558.

Who is the listed applicant for VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)?

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 VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)?

The FDA product code for VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) is FEB.

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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 SPONGESK973085ULTRACELL PACKING WITH SLEEVEK972635ULTRACELL SUCTION SPONGE

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Related Devices (Code: FEB)

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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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