Cleared Traditional

K171619 - 14Fr Colon Decompression Set, Macon Colon Decompression Set (FDA 510(k) Clearance)

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

K171619 · Cook Ireland, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
60d
Days
Class 2
Risk

K171619 is an FDA 510(k) clearance for the 14Fr Colon Decompression Set, Macon Colon Decompression Set. Classified as Tube, Double Lumen For Intestinal Decompression And/or Intubation (product code FEG), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on August 1, 2017 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Cook Ireland, Ltd. devices

Submission Details

510(k) Number K171619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2017
Decision Date August 01, 2017
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEG Tube, Double Lumen For Intestinal Decompression And/or Intubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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.