FDA 510(k)

Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

K-Number: K163058 · 2017-01-30

Decision Date2017-01-30

Product CodeODG

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K163058. 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 Slimline (SL) Endoscopic Ultrasound Aspiration Needle?

Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle is a medical device that received FDA 510(k) clearance on 2017-01-30. The listed applicant is Boston Scientific. The 510(k) number is K163058.

When did Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle receive FDA 510(k) clearance?

Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle received FDA 510(k) clearance on 2017-01-30, under 510(k) number K163058.

Who is the listed applicant for Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle?

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

What is the FDA product code for Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle?

The FDA product code for Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle is ODG.

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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.