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FDA 510(k)

PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM

K-Number: K954596 · 1995-10-07

ApplicantPromedical , Ltd.
Decision Date1995-10-07
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Promedical , Ltd.. It received FDA 510(k) clearance on 1995-10-07 under 510(k) number K954596. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM?

PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Promedical , Ltd.. The 510(k) number is K954596.

When did PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM receive FDA 510(k) clearance?

PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM received FDA 510(k) clearance on 1995-10-07, under 510(k) number K954596.

Who is the listed applicant for PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM?

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 PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM?

The FDA product code for PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM is FCG.

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.

K952350JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)K951598PRO-B BIOPSY NEEDLEK944944CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLEK944942BREAST LESION LOCALIZATION NEEDLE

Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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