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FDA 510(k)

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

K-Number: K952350 · 1995-07-17

ApplicantPromedical , Ltd.
Decision Date1995-07-17
Product CodeLWE
DecisionSubstantially Equivalent

Device Summary

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) is the device name listed in this FDA 510(k) record. The listed applicant is Promedical , Ltd.. It received FDA 510(k) clearance on 1995-07-17 under 510(k) number K952350. The device is classified under product code LWE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)?

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Promedical , Ltd.. The 510(k) number is K952350.

When did JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) receive FDA 510(k) clearance?

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) received FDA 510(k) clearance on 1995-07-17, under 510(k) number K952350.

Who is the listed applicant for JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)?

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

What is the FDA product code for JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)?

The FDA product code for JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) is LWE.

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 Promedical , Ltd. 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.

K954596PRO-B CORE-RECT COAXIAL BIOPSY SYSTEMK951598PRO-B BIOPSY NEEDLEK944944CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLEK944942BREAST LESION LOCALIZATION NEEDLE

Related Devices (Code: LWE)

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.

K913306BONE-TEMNO/STERNUM-TEMNOProact, Ltd.K871198BONE MARROW COLLECTION KIT AND STANDBaxter Healthcare 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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