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FDA 510(k)

ECHOTIP ULTRA ULTRASOUND NEEDLE

K-Number: K083330 · 2009-02-06

ApplicantCook Endoscopy
Decision Date2009-02-06
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ECHOTIP ULTRA ULTRASOUND NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Endoscopy. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K083330. 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 ECHOTIP ULTRA ULTRASOUND NEEDLE?

ECHOTIP ULTRA ULTRASOUND NEEDLE is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Cook Endoscopy. The 510(k) number is K083330.

When did ECHOTIP ULTRA ULTRASOUND NEEDLE receive FDA 510(k) clearance?

ECHOTIP ULTRA ULTRASOUND NEEDLE received FDA 510(k) clearance on 2009-02-06, under 510(k) number K083330.

Who is the listed applicant for ECHOTIP ULTRA ULTRASOUND NEEDLE?

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

What is the FDA product code for ECHOTIP ULTRA ULTRASOUND NEEDLE?

The FDA product code for ECHOTIP ULTRA ULTRASOUND 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.

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Other records listing Cook Endoscopy 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.

K192697Instinct Plus Endoscopic Clipping DeviceK090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONK061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON

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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