Cleared Traditional

K222705 - Introducer Needle

K222705 · Youcare Technology Co.,Ltd. (Wuhan) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
257d
Days
-
Risk

K222705 is an FDA 510(k) clearance for the Introducer Needle. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Youcare Technology Co.,Ltd. (Wuhan) (Wuhan, CN). The FDA issued a Cleared decision on May 22, 2023 after a review of 257 days - an extended review cycle.

This device falls under the General & Plastic Surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Youcare Technology Co.,Ltd. (Wuhan) devices

FDA 510(k) Submission Details - K222705

510(k) Number K222705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2022
Decision Date May 22, 2023
Days to Decision 257 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 115d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 50
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K222705.
Disposable Percutaneous Nephrostomy Dilatation Kit
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Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
K211911 · Coloplast Corp. · Mar 2022
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
K201165 · Coloplast Corp. · Dec 2020
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