Cleared Traditional

K211911 - Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets (FDA 510(k) Clearance)

K211911 · Coloplast Corp. · Gastroenterology & Urology device
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Mar 2022
Decision
262d
Days
-
Risk

K211911 is an FDA 510(k) clearance for the Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy .... Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on March 10, 2022 after a review of 262 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Coloplast Corp. devices

Submission Details

510(k) Number K211911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 21, 2021
Decision Date March 10, 2022
Days to Decision 262 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
132d slower than avg
Panel avg: 130d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -