Cleared Traditional

K253295 - Coude Sleeved IC

Also marketed or referenced as:
Coude Plus Sleeved IC

K253295 is the FDA 510(k) clearance for Coude Sleeved IC by Hollister Incorporated. It is a Class 2 Gastroenterology & Urology device (product code EZD) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K253295 · Hollister Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
231d
Days
Class 2
Risk

K253295 is an FDA 510(k) clearance for the Coude Sleeved IC. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on May 18, 2026 after a review of 231 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Hollister Incorporated devices

Submission Details

510(k) Number K253295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date May 18, 2026
Days to Decision 231 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
101d slower than avg
Panel avg: 130d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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.

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