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FDA 510(k)

GAUZE SPONGE, X-RAY DETECTABLE

K-Number: K882708 · 1988-08-03

ApplicantBioseal
Decision Date1988-08-03
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGE, X-RAY DETECTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Bioseal. It received FDA 510(k) clearance on 1988-08-03 under 510(k) number K882708. 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 GAUZE SPONGE, X-RAY DETECTABLE?

GAUZE SPONGE, X-RAY DETECTABLE is a medical device that received FDA 510(k) clearance on 1988-08-03. The listed applicant is Bioseal. The 510(k) number is K882708.

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

GAUZE SPONGE, X-RAY DETECTABLE received FDA 510(k) clearance on 1988-08-03, under 510(k) number K882708.

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

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

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

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

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Other records listing Bioseal 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.

K893814SURGICAL INSTRUMENT KIT, DISPOSABLEK882695RUBBER BAND, STERILEK882696DERMICEL, MONTGOMERY STRAPK882694FIXATION DEVICE, TRACH TUBEK882710INTESTINAL SPONGESK882709TONSIL SPONGE, X-RAY DETECTABLE, W/STRING

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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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