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FDA 510(k)

LAP SPONGE PRODUCT LINE

K-Number: K941344 · 1994-05-12

ApplicantCush Medical Products
Decision Date1994-05-12
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAP SPONGE PRODUCT LINE is the device name listed in this FDA 510(k) record. The listed applicant is Cush Medical Products. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K941344. 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 PRODUCT LINE?

LAP SPONGE PRODUCT LINE is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Cush Medical Products. The 510(k) number is K941344.

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

LAP SPONGE PRODUCT LINE received FDA 510(k) clearance on 1994-05-12, under 510(k) number K941344.

Who is the listed applicant for LAP SPONGE PRODUCT LINE?

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

What is the FDA product code for LAP SPONGE PRODUCT LINE?

The FDA product code for LAP SPONGE PRODUCT LINE is GDY.

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Other records listing Cush Medical Products 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.

K943424CUSH ISLAND DRESSINGK940518C-SECTION TRAYK941349DENTAL TRAYK941645BIOPSY TRAYK940239EYE TRAYK935684IV START KIT

View all 23 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.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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