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FDA 510(k)

SURGICAL SPONGE X-RAY DETECTABLE

K-Number: K935993 · 1994-02-02

ApplicantMcneil Healthcare, Inc.
Decision Date1994-02-02
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL SPONGE X-RAY DETECTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Mcneil Healthcare, Inc.. It received FDA 510(k) clearance on 1994-02-02 under 510(k) number K935993. 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 SURGICAL SPONGE X-RAY DETECTABLE?

SURGICAL SPONGE X-RAY DETECTABLE is a medical device that received FDA 510(k) clearance on 1994-02-02. The listed applicant is Mcneil Healthcare, Inc.. The 510(k) number is K935993.

When did SURGICAL SPONGE X-RAY DETECTABLE receive FDA 510(k) clearance?

SURGICAL SPONGE X-RAY DETECTABLE received FDA 510(k) clearance on 1994-02-02, under 510(k) number K935993.

Who is the listed applicant for SURGICAL SPONGE X-RAY DETECTABLE?

The FDA 510(k) record lists Mcneil Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL SPONGE X-RAY DETECTABLE?

The FDA product code for SURGICAL SPONGE X-RAY DETECTABLE is GDY.

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Other records listing Mcneil Healthcare, 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.

K935883NEUROLOGICAL SPONGESK935930NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSINGK935882TONSIL SPONGESK935934NON ADHERANT BURN PADSK935881SPECIALTY SPONGESK935910X-RAY PACKING SPONGE

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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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