Cleared Traditional

K163058 - Expect Slimline (SL) Endoscopic Ultraso...

K163058 is the FDA 510(k) clearance for Expect Slimline (SL) Endoscopic Ultraso... by Boston Scientific. It is a Class 2 Gastroenterology & Urology device (product code ODG) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K163058 · Boston Scientific · Gastroenterology & Urology device
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Jan 2017
Decision
90d
Days
Class 2
Risk

K163058 is an FDA 510(k) clearance for the Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle. Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by Boston Scientific (Marlboro, US). The FDA issued a Cleared decision on January 30, 2017 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific devices

Submission Details

510(k) Number K163058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2016
Decision Date January 30, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODG Endoscopic Ultrasound System, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ODG Endoscopic Ultrasound System, Gastroenterology-urology

All 31
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K163058.
Ultramatrix EUS Balloon
K180731 · United States Endoscopy Group, Inc. (Us Endoscopy) · Apr 2018
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
K171207 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2018
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K173184 · Boston Scientific · Oct 2017
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K160845 · Boston Scientific Corporation · May 2016
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · Boston Scientific Corporation · Jan 2014
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K112198 · Boston Scientific Corporation · Sep 2011