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FDA 510(k)

DUPAQUE SPONGE

K-Number: K941217 · 1994-04-21

ApplicantDumex Medical Surgical Products, Ltd.
Decision Date1994-04-21
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUPAQUE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Dumex Medical Surgical Products, Ltd.. It received FDA 510(k) clearance on 1994-04-21 under 510(k) number K941217. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPAQUE SPONGE?

DUPAQUE SPONGE is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Dumex Medical Surgical Products, Ltd.. The 510(k) number is K941217.

When did DUPAQUE SPONGE receive FDA 510(k) clearance?

DUPAQUE SPONGE received FDA 510(k) clearance on 1994-04-21, under 510(k) number K941217.

Who is the listed applicant for DUPAQUE SPONGE?

The FDA 510(k) record lists Dumex Medical Surgical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUPAQUE SPONGE?

The FDA product code for DUPAQUE SPONGE is GDY.

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Other records listing Dumex Medical Surgical Products, Ltd. 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.

K992732STERILE WATER & STERILE 0.9% SODIUM CHLORIDEK993119STERILE HYDROGELK990332DUMEX IODOFORM PACKING STRIPK980779THALAFIX NATURAL SEA SALT DRESSINGK980861DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGELK980863DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)

View all 13 devices →

Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives Corp.

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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