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FDA 510(k)

QUALTEX NEUROLOK SURGICAL SPONGE

K-Number: K884790 · 1988-12-09

ApplicantDeroyal Industries, Inc.
Decision Date1988-12-09
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUALTEX NEUROLOK SURGICAL SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1988-12-09 under 510(k) number K884790. 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 QUALTEX NEUROLOK SURGICAL SPONGE?

QUALTEX NEUROLOK SURGICAL SPONGE is a medical device that received FDA 510(k) clearance on 1988-12-09. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K884790.

When did QUALTEX NEUROLOK SURGICAL SPONGE receive FDA 510(k) clearance?

QUALTEX NEUROLOK SURGICAL SPONGE received FDA 510(k) clearance on 1988-12-09, under 510(k) number K884790.

Who is the listed applicant for QUALTEX NEUROLOK SURGICAL SPONGE?

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

What is the FDA product code for QUALTEX NEUROLOK SURGICAL SPONGE?

The FDA product code for QUALTEX NEUROLOK SURGICAL SPONGE is GDY.

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Related Devices (Code: GDY)

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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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