Cleared Special

K173184 - Expect Slimline (SL) Endoscopic Ultraso...

K173184 is an FDA 510(k) clearance for Expect Slimline (SL) Endoscopic Ultraso..., manufactured by Boston Scientific. The device is a Class 2 Gastroenterology & Urology device with product code ODG cleared through the Special 510(k) pathway after a 28-day FDA review.

K173184 · Boston Scientific · Gastroenterology & Urology device
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Oct 2017
Decision
28d
Days
Class 2
Risk

K173184 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 October 27, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific devices

FDA 510(k) Submission Details - K173184

510(k) Number K173184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date October 27, 2017
Days to Decision 28 days
Submission Type Special
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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

ODG Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K173184.
PENTAX Medical Endoscopic Ultrasound System
K182004 · Pentax of America, Inc. · Aug 2018
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
Endoscopic Ultrasound Aspiration Needle
K172309 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2017
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
K162447 · Pentax of America, Inc. · Apr 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K163058 · Boston Scientific · Jan 2017