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FDA 510(k)

CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES

K-Number: K924271 · 1992-11-23

ApplicantCore Medical, Inc.
Decision Date1992-11-23
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Core Medical, Inc.. It received FDA 510(k) clearance on 1992-11-23 under 510(k) number K924271. 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 NEEDLES?

CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES is a medical device that received FDA 510(k) clearance on 1992-11-23. The listed applicant is Core Medical, Inc.. The 510(k) number is K924271.

When did CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES receive FDA 510(k) clearance?

CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES received FDA 510(k) clearance on 1992-11-23, under 510(k) number K924271.

Who is the listed applicant for CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES?

The FDA 510(k) record lists Core Medical, 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 NEEDLES?

The FDA product code for CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES 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 Core Medical, 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.

K924270BREAST LESION LOCALIZATION NEEDLEK914732CORE MEDICAL BIOPSY 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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