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FDA 510(k)

SURGICAL SPONGES

K-Number: K920356 · 1992-08-06

ApplicantUltracell Medical Technologies, Inc.
Decision Date1992-08-06
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Ultracell Medical Technologies, Inc.. It received FDA 510(k) clearance on 1992-08-06 under 510(k) number K920356. 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 SURGICAL SPONGES?

SURGICAL SPONGES is a medical device that received FDA 510(k) clearance on 1992-08-06. The listed applicant is Ultracell Medical Technologies, Inc.. The 510(k) number is K920356.

When did SURGICAL SPONGES receive FDA 510(k) clearance?

SURGICAL SPONGES received FDA 510(k) clearance on 1992-08-06, under 510(k) number K920356.

Who is the listed applicant for SURGICAL SPONGES?

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

What is the FDA product code for SURGICAL SPONGES?

The FDA product code for SURGICAL SPONGES is GDY.

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Other records listing Ultracell Medical Technologies, 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.

K012196ULTRACELL ABSORBENT STICKK972634ULTRACELL SUCTION SPONGEK972633ULTRACELL SUCTION SPONGEK973083ULTRACELL NEURO SPONGESK973558VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)K973085ULTRACELL PACKING WITH SLEEVE

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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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