Cleared Traditional

DiLumen C2 (K173317) - FDA 510(k) Clearance

Also marketed or referenced as:
DiLumen Tool Mount

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173317 · Lumendi, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
180d
Days
Class 2
Risk

K173317 is an FDA 510(k) clearance for the DiLumen C2. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Lumendi, LLC (Westport, US). The FDA issued a Cleared decision on April 17, 2018 after a review of 180 days - an extended review cycle.

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 Lumendi, LLC devices

Submission Details

510(k) Number K173317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2017
Decision Date April 17, 2018
Days to Decision 180 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
50d slower than avg
Panel avg: 130d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum 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

Hogan Lovells US LLP
John J. Smith

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 - FDF Colonoscope And Accessories, Flexible/rigid

All 41
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K173317.
DiLumen Endolumenal Interventional Platform
K182540 · Lumendi, LLC · Oct 2018
PENTAX Medical Video Colonoscope EC34-i10T Series
K180285 · Pentax Medical of America, Inc. · Oct 2018
Pure Vu System
K181437 · Motus GI Medical Technologies , Ltd. · Jun 2018
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K180405 · Fujifilm Corporation · Mar 2018
Focus Cap
K171673 · Gce Medical Corporation · Jan 2018
invendoscopy E210 System
K173085 · Invendo Medical GmbH · Jan 2018