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FDA 510(k)

RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE

K-Number: K100712 · 2010-03-30

ApplicantBoston Scientific Corporation
Decision Date2010-03-30
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2010-03-30 under 510(k) number K100712. 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 RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE?

RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE is a medical device that received FDA 510(k) clearance on 2010-03-30. The listed applicant is Boston Scientific Corporation. The 510(k) number is K100712.

When did RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE receive FDA 510(k) clearance?

RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE received FDA 510(k) clearance on 2010-03-30, under 510(k) number K100712.

Who is the listed applicant for RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE?

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

What is the FDA product code for RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE?

The FDA product code for RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE is FCG.

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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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