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FDA 510(k)

SPIGAL NEEDLE

K-Number: K980676 · 1998-05-21

ApplicantGallini U.S., LLC
Decision Date1998-05-21
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPIGAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Gallini U.S., LLC. It received FDA 510(k) clearance on 1998-05-21 under 510(k) number K980676. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIGAL NEEDLE?

SPIGAL NEEDLE is a medical device that received FDA 510(k) clearance on 1998-05-21. The listed applicant is Gallini U.S., LLC. The 510(k) number is K980676.

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

SPIGAL NEEDLE received FDA 510(k) clearance on 1998-05-21, under 510(k) number K980676.

Who is the listed applicant for SPIGAL NEEDLE?

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

What is the FDA product code for SPIGAL NEEDLE?

The FDA product code for SPIGAL NEEDLE is KNW.

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Other records listing Gallini U.S., LLC 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.

K992499GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLEK990645GALLINI ATRA-CUT NEEDLEK990716GALLINI BYCUT NEEDLEK981301SPEED-CUT AUTOMATIC BIOPSY SYSTEMK980479QUICK-CUT AUTOMATIC BIOPSY SYSTEMK980248ACRI R NEEDLE

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Related Devices (Code: KNW)

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.

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

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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