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FDA 510(k)

LAPAROTOMY SPONGE

K-Number: K810184 · 1981-02-04

ApplicantMedical Action Industries, Inc.
Decision Date1981-02-04
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAPAROTOMY SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Action Industries, Inc.. It received FDA 510(k) clearance on 1981-02-04 under 510(k) number K810184. 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 LAPAROTOMY SPONGE?

LAPAROTOMY SPONGE is a medical device that received FDA 510(k) clearance on 1981-02-04. The listed applicant is Medical Action Industries, Inc.. The 510(k) number is K810184.

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

LAPAROTOMY SPONGE received FDA 510(k) clearance on 1981-02-04, under 510(k) number K810184.

Who is the listed applicant for LAPAROTOMY SPONGE?

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

What is the FDA product code for LAPAROTOMY SPONGE?

The FDA product code for LAPAROTOMY SPONGE is GDY.

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Other records listing Medical Action Industries, 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.

K042526DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BXK042527SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107K022948VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555LK946019SURGICLA INSTRUMENT KITK923846BURN DRESSINGK884826GAUZE SPONGE

View all 8 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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