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FDA 510(k)

CHIBA NEEDLE

K-Number: K012358 · 2001-10-15

ApplicantIspg, Inc.
Decision Date2001-10-15
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHIBA NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Ispg, Inc.. It received FDA 510(k) clearance on 2001-10-15 under 510(k) number K012358. 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 NEEDLE?

CHIBA NEEDLE is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Ispg, Inc.. The 510(k) number is K012358.

When did CHIBA NEEDLE receive FDA 510(k) clearance?

CHIBA NEEDLE received FDA 510(k) clearance on 2001-10-15, under 510(k) number K012358.

Who is the listed applicant for CHIBA NEEDLE?

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

What is the FDA product code for CHIBA NEEDLE?

The FDA product code for CHIBA NEEDLE 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 Ispg, 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.

K962886ANESTHESIA CONDUCTION NEEDLEK962042GLASS SYRINGEK950133HYPODERMIC SYRINGE PISTON

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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