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FDA 510(k)

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE

K-Number: K945146 · 1994-12-21

ApplicantPromex, Inc.
Decision Date1994-12-21
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 1994-12-21 under 510(k) number K945146. 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 CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE?

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is Promex, Inc.. The 510(k) number is K945146.

When did CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE receive FDA 510(k) clearance?

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE received FDA 510(k) clearance on 1994-12-21, under 510(k) number K945146.

Who is the listed applicant for CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE?

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

What is the FDA product code for CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE?

The FDA product code for CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE is FCG.

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Other records listing Promex, 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.

K023450BIOPSY SITE TISSUE MARKER DEVICEK022634CO-AXIAL INTRODUCER NEEDLEK010400VACUUM ASSISTED CORE BIOPSY DEVICEK011270AUTOMATED CORE BIOPSY DEVICEK001132BONE BIOPSY NEEDLEK994272AUTOMATED CORE BIOPSY DEVICE

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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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