Cleared Special

K110030 - EXPECT ENDOSCOPIC ASPIRATION NEEDLE

K110030 is an FDA 510(k) clearance for EXPECT ENDOSCOPIC ASPIRATION NEEDLE, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code ODG cleared through the Special 510(k) pathway after a 7-day FDA review.

K110030 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
7d
Days
Class 2
Risk

K110030 is an FDA 510(k) clearance for the EXPECT ENDOSCOPIC ASPIRATION NEEDLE. Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on January 12, 2011 after a review of 7 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.

FDA 510(k) Submission Details - K110030

510(k) Number K110030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2011
Decision Date January 12, 2011
Days to Decision 7 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 131d · This submission: 7d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Intertek Testing Services
PAULA WILKERSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODG Endoscopic Ultrasound System, Gastroenterology-urology

All 43
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K110030.
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 ULTRASOUND ASPIRATION NEEDLE
K112198 · Boston Scientific Corporation · Sep 2011
EG-3670URK
K090196 · Pentax Medical Company · May 2009
EG-3870UTK
K090197 · Pentax Medical Company · May 2009
EG-3670URK
K061068 · Pentax Medical Company · May 2006

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K110030 · EXPECT ENDOSCOPIC ASPIRATION NEEDLE
Download PDF FDA Summary Boston Scientific Corp