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FDA 510(k)

X-RAY DETECTABLE BAND

K-Number: K812017 · 1981-11-20

ApplicantIsramed, Inc.
Decision Date1981-11-20
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

X-RAY DETECTABLE BAND is the device name listed in this FDA 510(k) record. The listed applicant is Isramed, Inc.. It received FDA 510(k) clearance on 1981-11-20 under 510(k) number K812017. 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 X-RAY DETECTABLE BAND?

X-RAY DETECTABLE BAND is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is Isramed, Inc.. The 510(k) number is K812017.

When did X-RAY DETECTABLE BAND receive FDA 510(k) clearance?

X-RAY DETECTABLE BAND received FDA 510(k) clearance on 1981-11-20, under 510(k) number K812017.

Who is the listed applicant for X-RAY DETECTABLE BAND?

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

What is the FDA product code for X-RAY DETECTABLE BAND?

The FDA product code for X-RAY DETECTABLE BAND is GDY.

Related Clinical Trials

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.

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Other records listing Isramed, 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.

K813537URIFIXK812018X-RAY DETECTABLE THREAD

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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