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FDA 510(k)

TONSIL SPONGES

K-Number: K935882 · 1994-01-31

ApplicantMcneil Healthcare, Inc.
Decision Date1994-01-31
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TONSIL SPONGES 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 1994-01-31 under 510(k) number K935882. 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 TONSIL SPONGES?

TONSIL SPONGES is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is Mcneil Healthcare, Inc.. The 510(k) number is K935882.

When did TONSIL SPONGES receive FDA 510(k) clearance?

TONSIL SPONGES received FDA 510(k) clearance on 1994-01-31, under 510(k) number K935882.

Who is the listed applicant for TONSIL SPONGES?

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 TONSIL SPONGES?

The FDA product code for TONSIL SPONGES is GDY.

Related Clinical Trials

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.

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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.

K935930NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSINGK935883NEUROLOGICAL SPONGESK935993SURGICAL SPONGE X-RAY DETECTABLEK935934NON ADHERANT BURN PADSK935881SPECIALTY SPONGESK935910X-RAY PACKING SPONGE

View all 19 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.K953058ROUND STICK SPONGES, FLAT STICK SPONGESMedical 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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