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FDA 510(k)

LAP SPONGE

K-Number: K782107 · 1979-02-16

ApplicantCarapace, Inc.
Decision Date1979-02-16
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAP SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Carapace, Inc.. It received FDA 510(k) clearance on 1979-02-16 under 510(k) number K782107. 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 LAP SPONGE?

LAP SPONGE is a medical device that received FDA 510(k) clearance on 1979-02-16. The listed applicant is Carapace, Inc.. The 510(k) number is K782107.

When did LAP SPONGE receive FDA 510(k) clearance?

LAP SPONGE received FDA 510(k) clearance on 1979-02-16, under 510(k) number K782107.

Who is the listed applicant for LAP SPONGE?

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

What is the FDA product code for LAP SPONGE?

The FDA product code for LAP SPONGE is GDY.

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Other records listing Carapace, 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.

K931722CARAPACE LABOR AND DELIVERY SETSK931822CARAPACE PELVIC EXAM TRAYSK931729I.V. START KITK931820CARAPACE STILLWATER BOWL SETK931669CARAPACE DEBRIDEMENT KITSK931760CARAPACE PACKING GAUZE TRAYS

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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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