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FDA 510(k)

STERILE X-RAY DETECTABLE GAUZE SPONGES

K-Number: K941522 · 1994-05-12

ApplicantCush Medical Products
Decision Date1994-05-12
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE X-RAY DETECTABLE GAUZE SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Cush Medical Products. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K941522. 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 STERILE X-RAY DETECTABLE GAUZE SPONGES?

STERILE X-RAY DETECTABLE GAUZE SPONGES is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Cush Medical Products. The 510(k) number is K941522.

When did STERILE X-RAY DETECTABLE GAUZE SPONGES receive FDA 510(k) clearance?

STERILE X-RAY DETECTABLE GAUZE SPONGES received FDA 510(k) clearance on 1994-05-12, under 510(k) number K941522.

Who is the listed applicant for STERILE X-RAY DETECTABLE GAUZE SPONGES?

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

What is the FDA product code for STERILE X-RAY DETECTABLE GAUZE SPONGES?

The FDA product code for STERILE X-RAY DETECTABLE GAUZE SPONGES is GDY.

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Other records listing Cush Medical Products 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.

K943424CUSH ISLAND DRESSINGK940518C-SECTION TRAYK941349DENTAL TRAYK941645BIOPSY TRAYK940239EYE TRAYK935684IV START KIT

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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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