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FDA 510(k)

ULTRACELL INSTRUMENT WIPE

K-Number: K920353 · 1992-09-15

ApplicantUltracell Medical Technologies, Inc.
Decision Date1992-09-15
Product CodeHEP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRACELL INSTRUMENT WIPE 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 1992-09-15 under 510(k) number K920353. The device is classified under product code HEP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACELL INSTRUMENT WIPE?

ULTRACELL INSTRUMENT WIPE is a medical device that received FDA 510(k) clearance on 1992-09-15. The listed applicant is Ultracell Medical Technologies, Inc.. The 510(k) number is K920353.

When did ULTRACELL INSTRUMENT WIPE receive FDA 510(k) clearance?

ULTRACELL INSTRUMENT WIPE received FDA 510(k) clearance on 1992-09-15, under 510(k) number K920353.

Who is the listed applicant for ULTRACELL INSTRUMENT WIPE?

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 INSTRUMENT WIPE?

The FDA product code for ULTRACELL INSTRUMENT WIPE is HEP.

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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 STICKK972634ULTRACELL SUCTION SPONGEK972633ULTRACELL SUCTION SPONGEK973083ULTRACELL NEURO SPONGESK973558VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)K973085ULTRACELL PACKING WITH SLEEVE

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Related Devices (Code: HEP)

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.

K101960SONOTRAX SERIES ULTRASONIC POCKET DOPPLEREdan Instruments, Inc.K023082BABYCAREBionet Company, Ltd.K910462POCKET DOP 3Imex Medical Systems, Inc.

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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