Cleared Special

K112198 - EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION...

K112198 is the FDA 510(k) clearance for EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION... by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code ODG) cleared through the Special 510(k) pathway after a 44-day FDA review.

K112198 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
44d
Days
Class 2
Risk

K112198 is an FDA 510(k) clearance for the EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE. Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on September 14, 2011 after a review of 44 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 Corporation devices

Submission Details

510(k) Number K112198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2011
Decision Date September 14, 2011
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

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 36
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K112198.
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · Boston Scientific Corporation · Jan 2014
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130206 · Pentax of America, Inc. · Mar 2013
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130247 · Pentax of America, Inc. · Mar 2013
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
K110030 · Boston Scientific Corp · Jan 2011
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K031789 · Pentax Precision Instrument Corp. · Aug 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K023401 · Pentax Precision Instrument Corp. · Feb 2003