Chrysalis Intelligence · Product Codes · LJE

LJE · Unclassified

5 clearances · 4 unique sponsors

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Device class

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Regulation —

Total clearances

5

2020-01-29 → 2025-07-03

Last 12 months

0

Unique sponsors

4

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Coloplast Corp.	2	0	2022-03-10
Shenzhen Trious Medical Technology Co., Ltd.	1	0	2025-07-03
Cook Incorporated	1	0	2020-01-29
Youcare Technology Co.,Ltd. (Wuhan)	1	0	2023-05-22

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-07-03	K250448	Shenzhen Trious Medical Technology Co., Ltd.	Disposable Percutaneous Nephrostomy Dilatation Kit
2023-05-22	K222705	Youcare Technology Co.,Ltd. (Wuhan)	Introducer Needle
2022-03-10	K211911	Coloplast Corp.	Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
2020-12-17	K201165	Coloplast Corp.	In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
2020-01-29	K191498	Cook Incorporated	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc