Cleared Traditional

K222705 - Introducer Needle (FDA 510(k) Clearance)

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

Submission Details

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
143d slower than avg
Panel avg: 114d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 55
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K222705.
Disposable Percutaneous Nephrostomy Dilatation Kit
K250448 · Shenzhen Trious Medical Technology Co., Ltd. · Jul 2025
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
K211911 · Coloplast Corp. · Mar 2022
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
K191498 · Cook Incorporated · Jan 2020