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FDA 510(k)

EXPECT ENDOSCOPIC ASPIRATION NEEDLE

K-Number: K110030 · 2011-01-12

ApplicantBoston Scientific Corp
Decision Date2011-01-12
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXPECT ENDOSCOPIC ASPIRATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2011-01-12 under 510(k) number K110030. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPECT ENDOSCOPIC ASPIRATION NEEDLE?

EXPECT ENDOSCOPIC ASPIRATION NEEDLE is a medical device that received FDA 510(k) clearance on 2011-01-12. The listed applicant is Boston Scientific Corp. The 510(k) number is K110030.

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

EXPECT ENDOSCOPIC ASPIRATION NEEDLE received FDA 510(k) clearance on 2011-01-12, under 510(k) number K110030.

Who is the listed applicant for EXPECT ENDOSCOPIC ASPIRATION NEEDLE?

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

What is the FDA product code for EXPECT ENDOSCOPIC ASPIRATION NEEDLE?

The FDA product code for EXPECT ENDOSCOPIC ASPIRATION NEEDLE is ODG.

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Related Devices (Code: ODG)

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.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK260428RIVOS™ EUS Access Device (M00553900)Boston Scientific CorporationK251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK251542InstaFANOnepass Medical , Ltd.K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, 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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