Product code LJE
- Device name
- Catheter, Nephrostomy
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd. | 2025-07-03 |
| K222705 | Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) | 2023-05-22 |
| K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | Coloplast Corp. | 2022-03-10 |
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | Coloplast Corp. | 2020-12-17 |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | Cook Incorporated | 2020-01-29 |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | Cook Incorporated | 2019-12-16 |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | Cook Incorporated | 2019-07-16 |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | Cook Incorporated | 2019-05-17 |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | Cook Incorporated | 2019-03-27 |
| K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | 2018-08-17 |
| K171601 | Ultraxx Nephrostomy Balloon Catheter | Cook Incorporated | 2018-02-23 |
| K172929 | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath | Boston Scientific Corporation | 2018-01-10 |
| 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 | 2017-10-19 |
| K160077 | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set | Jbw7 Innovations, LLC | 2016-07-12 |
| K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER | Gyrus Acmi, Inc. | 2014-02-04 |
| K121614 | NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER | Boston Scientific Corp | 2012-09-18 |
| K080944 | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | 2008-10-23 |
| K063632 | X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | 2007-01-05 |
| K051316 | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | C.R. Bard, Inc. | 2005-07-18 |
| K024050 | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET | Cook Urological, Inc. | 2003-02-27 |
| K011121 | RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS | Rusch Intl. | 2001-11-16 |
| K990689 | ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 | Zcv ,Inc. | 1999-09-03 |
| K981344 | URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING | Uresil Corp. | 1998-09-10 |
| K980193 | MANAN GENERAL UTILITY DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-05-27 |
| K980192 | MANAN NEPHROSTOMY DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-05-27 |
| K980889 | URESIL NEPHRO-URETERAL STENT | Uresil Corp. | 1998-04-08 |
| K961933 | CIRCLE NEPHROSTOMY CATHETER SET | Cook Urological, Inc. | 1996-07-18 |
| K953713 | MANAN GENERAL UTILITY DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 |
| K953601 | MANAN UNIVERSAL SUMP DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 |
| K953547 | MANAN NEPHROSTOMY DRAINAGE CATHETER | Manan Medical Products, Inc. | 1995-08-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729077589 | NephroMax Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729834540 | NephroMax Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729834533 | NephroMax Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729834526 | NephroMax Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729826507 | NephroMax | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729826491 | NephroMax | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729826484 | NephroMax | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729012641 | NephroMax | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| H862NSL21026H0 | Nephro-Stent Nephroureteral Stent Catheter | URESIL, LLC | 2016-09-07 |
| H862NSL21024H0 | Nephro-Stent Nephroureteral Stent Catheter | URESIL, LLC | 2016-09-06 |
| H862NSL21022H0 | Nephro-Stent Nephroureteral Stent Catheter | URESIL, LLC | 2016-09-06 |
| H862NSL20828H0 | Nephro-Stent Nephroureteral Stent Catheter | URESIL, LLC | 2016-09-06 |
| H862NSL20826H0 | Nephro-Stent Nephroureteral Stent Catheter | URESIL, LLC | 2016-09-06 |
| H862NSL20824H0 | Nephro-Stent Nephroureteral Stent Catheter | URESIL, LLC | 2016-09-06 |
| H862NSL20822H0 | Nephro-Stent Nephroureteral Stent Catheter | URESIL, LLC | 2016-09-06 |
| 08714729880356 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2016-03-02 |
| 08714729880332 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729880370 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729880363 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729880349 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729297215 | Percuflex™ Urinary Diversion Stent Set | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729880325 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729297161 | Percuflex™ Urinary Diversion Stent Set | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729297178 | Percuflex™ Urinary Diversion Stent Set | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729297185 | Percuflex™ Urinary Diversion Stent Set | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729297192 | Percuflex™ Urinary Diversion Stent Set | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729297208 | Percuflex™ Urinary Diversion Stent Set | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729821151 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729821144 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729821137 | Percuflex™ Urinary Diversion Stent | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |