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FDA 510(k)

ULTRACELL PACKING WITH SLEEVE

K-Number: K973085 · 1997-11-18

ApplicantUltracell Medical Technologies, Inc.
Decision Date1997-11-18
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ULTRACELL PACKING WITH SLEEVE 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 1997-11-18 under 510(k) number K973085. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACELL PACKING WITH SLEEVE?

ULTRACELL PACKING WITH SLEEVE is a medical device that received FDA 510(k) clearance on 1997-11-18. The listed applicant is Ultracell Medical Technologies, Inc.. The 510(k) number is K973085.

When did ULTRACELL PACKING WITH SLEEVE receive FDA 510(k) clearance?

ULTRACELL PACKING WITH SLEEVE received FDA 510(k) clearance on 1997-11-18, under 510(k) number K973085.

Who is the listed applicant for ULTRACELL PACKING WITH SLEEVE?

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 PACKING WITH SLEEVE?

The FDA product code for ULTRACELL PACKING WITH SLEEVE is EMX.

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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)K972635ULTRACELL SUCTION SPONGE

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Related Devices (Code: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, 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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