Cleared Traditional

Habib EndoHPB (K180165) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K180165 · Emcision , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
57d
Days
Class 2
Risk

K180165 is an FDA 510(k) clearance for the Habib EndoHPB. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Emcision , Ltd. (London, GB). The FDA issued a Cleared decision on March 20, 2018 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emcision , Ltd. devices

Submission Details

510(k) Number K180165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2018
Decision Date March 20, 2018
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Lok North America, Inc.
Louis-Paul Marin

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.

Clinical Evidence

ClinicalTrials.gov
NCT01303159 Terminated Interventional

Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

Pilot Study to Assess Safety and Efficacy of an Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

29
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Cholangiocarcinoma; Pancreatic Cancer
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Michel Kahaleh, M.D.
Sponsor Weill Medical College of Cornell University
Started 2010-03-01 → Primary completion 2014-01-13
Primary outcome
Change From Baseline in Bile Duct Stricture Diameter
Secondary outcome
Number of Participants With Adverse Events
View full study on ClinicalTrials.gov

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 91
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