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FDA 510(k)

ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE

K-Number: K962570 · 1996-11-27

ApplicantGallini Intl., Inc.
Decision Date1996-11-27
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Gallini Intl., Inc.. It received FDA 510(k) clearance on 1996-11-27 under 510(k) number K962570. 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 ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE?

ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1996-11-27. The listed applicant is Gallini Intl., Inc.. The 510(k) number is K962570.

When did ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE receive FDA 510(k) clearance?

ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE received FDA 510(k) clearance on 1996-11-27, under 510(k) number K962570.

Who is the listed applicant for ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE?

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

What is the FDA product code for ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE?

The FDA product code for ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE is FCG.

Related Clinical Trials

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Other records listing Gallini Intl., 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.

K970872PAN (CHIBA ASPIRATING NEEDLE)K970871TR NEEDLEK964777TZK962569BIOMID BONE MARROW BIOPSY NEEDLEK962568ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLESK961407SPEED-CUT

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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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