Cleared Traditional

K183035 - Percutaneous Entry Set

K183035 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
197d
Days
-
Risk

K183035 is an FDA 510(k) clearance for the Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part .... Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 17, 2019 after a review of 197 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 Cook Incorporated devices

Submission Details

510(k) Number K183035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 01, 2018
Decision Date May 17, 2019
Days to Decision 197 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
67d slower than avg
Panel avg: 130d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 45
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K183035.
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
K191498 · Cook Incorporated · Jan 2020
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903 · Cook Incorporated · Dec 2019
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
K183051 · Cook Incorporated · Jul 2019
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
K181735 · Cook Incorporated · Mar 2019
Ultraxx Nephrostomy Balloon Catheter Set
K181713 · Cook Incorporated · Aug 2018
Ultraxx Nephrostomy Balloon Catheter
K171601 · Cook Incorporated · Feb 2018