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FDA 510(k)

BIP BIOPSY NEEDLE MODIFICATION

K-Number: K934370 · 1994-03-07

ApplicantBip USA, Inc.
Decision Date1994-03-07
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIP BIOPSY NEEDLE MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Bip USA, Inc.. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K934370. 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 BIP BIOPSY NEEDLE MODIFICATION?

BIP BIOPSY NEEDLE MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Bip USA, Inc.. The 510(k) number is K934370.

When did BIP BIOPSY NEEDLE MODIFICATION receive FDA 510(k) clearance?

BIP BIOPSY NEEDLE MODIFICATION received FDA 510(k) clearance on 1994-03-07, under 510(k) number K934370.

Who is the listed applicant for BIP BIOPSY NEEDLE MODIFICATION?

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

What is the FDA product code for BIP BIOPSY NEEDLE MODIFICATION?

The FDA product code for BIP BIOPSY NEEDLE MODIFICATION 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bip USA, 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.

K024089VACUFLASH BIOPSY SYSTEMK934371BIP MULTI MODIFICATIONK935457LOCALIZATION WIRE OR MARKER - SURGICALK925870SPACERK925875HORIZONTAL NEEDLE GUIDE ATTACHMENTK925874BREAST STABILIZER

View all 7 devices →

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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