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FDA 510(k)

ISOLYSER (18X18 X-RAY DETECTABLE)

K-Number: K940762 · 1994-05-02

ApplicantThantex Specialties, Inc.
Decision Date1994-05-02
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLYSER (18X18 X-RAY DETECTABLE) is the device name listed in this FDA 510(k) record. The listed applicant is Thantex Specialties, Inc.. It received FDA 510(k) clearance on 1994-05-02 under 510(k) number K940762. 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 ISOLYSER (18X18 X-RAY DETECTABLE)?

ISOLYSER (18X18 X-RAY DETECTABLE) is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is Thantex Specialties, Inc.. The 510(k) number is K940762.

When did ISOLYSER (18X18 X-RAY DETECTABLE) receive FDA 510(k) clearance?

ISOLYSER (18X18 X-RAY DETECTABLE) received FDA 510(k) clearance on 1994-05-02, under 510(k) number K940762.

Who is the listed applicant for ISOLYSER (18X18 X-RAY DETECTABLE)?

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

What is the FDA product code for ISOLYSER (18X18 X-RAY DETECTABLE)?

The FDA product code for ISOLYSER (18X18 X-RAY DETECTABLE) is GDY.

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Other records listing Thantex Specialties, 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.

K970547ISOLYSER SDS SHARPS CONTAINERK961083OREX SURGEON'S VESTK942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSK943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMSK945755OREX(R) O.R EQUIPMENT DRAPESK945223OREX ISOLATION GOWN

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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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