LJE · Catheter, Nephrostomy
· Class U
Overview
| Product Code | LJE |
|---|---|
| Device Name | Catheter, Nephrostomy |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd. | Jul 3, 2025 | SESE |
| K222705 | Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) | May 22, 2023 | SESE |
| K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | Coloplast Corp. | Mar 10, 2022 | SESK |
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | Coloplast Corp. | Dec 17, 2020 | SESK |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | Cook Incorporated | Jan 29, 2020 | SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | Cook Incorporated | Dec 16, 2019 | SESE |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | Cook Incorporated | Jul 16, 2019 | SESK |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | Cook Incorporated | May 17, 2019 | SESK |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | Cook Incorporated | Mar 27, 2019 | SESK |
| K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | Aug 17, 2018 | SESE |
| K171601 | Ultraxx Nephrostomy Balloon Catheter | Cook Incorporated | Feb 23, 2018 | SESE |
| K172929 | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath | Boston Scientific Corporation | Jan 10, 2018 | SESE |
| K172527 | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe | Cook Incorporated | Oct 19, 2017 | SESE |
| K160077 | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set | Jbw7 Innovations, LLC | Jul 12, 2016 | SESE |
| K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER | Gyrus Acmi, Inc. | Feb 4, 2014 | SESE |
| K121614 | NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER | Boston Scientific Corp | Sep 18, 2012 | SESE |
| K080944 | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | Oct 23, 2008 | SESE |
| K063632 | X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | Jan 5, 2007 | SESE |
| K051316 | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | Jul 18, 2005 | SESE |
| K024050 | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET | Cook Urological, Inc. | Feb 27, 2003 | SESE |
Top Applicants
- Cook Incorporated — 8 clearances
- Uresil Corp. — 5 clearances
- Cook Urological, Inc. — 4 clearances
- American Edwards Laboratories — 3 clearances
- C.R. Bard, Inc. — 3 clearances
