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FDA 510(k)

GAUZE & LAB SPONGES STERILE & NON

K-Number: K842572 · 1984-08-15

ApplicantUlti-Med Intl., Inc.
Decision Date1984-08-15
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAUZE & LAB SPONGES STERILE & NON is the device name listed in this FDA 510(k) record. The listed applicant is Ulti-Med Intl., Inc.. It received FDA 510(k) clearance on 1984-08-15 under 510(k) number K842572. 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 & LAB SPONGES STERILE & NON?

GAUZE & LAB SPONGES STERILE & NON is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Ulti-Med Intl., Inc.. The 510(k) number is K842572.

When did GAUZE & LAB SPONGES STERILE & NON receive FDA 510(k) clearance?

GAUZE & LAB SPONGES STERILE & NON received FDA 510(k) clearance on 1984-08-15, under 510(k) number K842572.

Who is the listed applicant for GAUZE & LAB SPONGES STERILE & NON?

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

What is the FDA product code for GAUZE & LAB SPONGES STERILE & NON?

The FDA product code for GAUZE & LAB SPONGES STERILE & NON is GDY.

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Other records listing Ulti-Med Intl., Inc. as applicant

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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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