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FDA 510(k)

AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT

K-Number: K954231 · 1995-09-22

ApplicantPromex, Inc.
Decision Date1995-09-22
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 1995-09-22 under 510(k) number K954231. 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 AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT?

AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT is a medical device that received FDA 510(k) clearance on 1995-09-22. The listed applicant is Promex, Inc.. The 510(k) number is K954231.

When did AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT receive FDA 510(k) clearance?

AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT received FDA 510(k) clearance on 1995-09-22, under 510(k) number K954231.

Who is the listed applicant for AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT?

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 AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT?

The FDA product code for AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT 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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