Product code KNY
- Device name
- Accessories, Catheter, G-U
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182144 | Bi-Flex Evo | Promepla Sam | 2018-09-07 |
| K162356 | Vesair Cystoscopic Sheath | Solace Therapeutics | 2017-03-02 |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | Promepla Sam | 2014-06-17 |
| K140562 | WIJAY EZ-VOID EXTERNAL CATHETER VALVE | Leomed, LLC | 2014-06-16 |
| K141252 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2014-06-09 |
| K131803 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2013-08-20 |
| K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH | Olympus Surgical Technologies America | 2013-02-04 |
| K120160 | ROCAMED ROCAUS PLATINUM | Promepla Sam | 2012-05-14 |
| K112209 | PREFILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2011-09-08 |
| K090121 | PRE-FILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2009-04-15 |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2006-12-12 |
| K062240 | CAREVENT | Chief Medical, LLC | 2006-10-16 |
| K052952 | CATHASSIST | Physician Technologies, Inc. | 2006-05-14 |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2005-09-22 |
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | Acmi Corporation | 2005-09-02 |
| K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2005-02-01 |
| K042877 | MICROVERTER URETERAL ACCESS SHEATH | Percutaneous Systems, Inc. | 2004-11-16 |
| K040520 | SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2004-05-20 |
| K032127 | HEMEDEX FIXATION DEVICE | Hemedex Incorporated | 2003-12-30 |
| K023690 | CATHETER CONNECTOR | World Metals, Inc. | 2003-02-28 |
| K000767 | MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 | Memcath Technologies, LLC | 2000-06-05 |
| K991097 | PBN DRAINAGE CATHETER GUIDEWIRES | Medical Device Technologies, Inc. | 1999-04-23 |
| K981611 | SNAP-N-PEEL INTRODUCERS | Circon Corp. | 1998-07-30 |
| K981667 | HYDROPHILIC COATED GUIDEWIRE | Lake Region Mfg., Inc. | 1998-06-05 |
| K981229 | MANAN MANTA CATHETER FIXATION DISK | Medical Device Technologies, Inc. | 1998-04-22 |
| K972977 | INSULATOR WIRE GUIDE | Cook Urological, Inc. | 1997-10-10 |
| K960866 | LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. | Lake Region Mfg., Inc. | 1996-04-05 |
| K954132 | MANAN MANTA CATHETER FIXATION DISK | Manan Medical Products, Inc. | 1996-03-26 |
| K952414 | PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER | Acacia Laboratories, Inc. | 1995-06-23 |
| K951995 | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR | Karl Storz Endoskop GmbH | 1995-05-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 50192253032336 | Dover | Cardinal Health 200, LLC | 2024-07-10 |
| 10192253027648 | Dover | Cardinal Health 200, LLC | 2024-07-10 |
| 00821925036345 | VARI-PASS | Gyrus ACMI, LLC | 2017-05-11 |
| 00821925035423 | UroPass | Gyrus ACMI, LLC | 2016-10-12 |
| 00821925035409 | UroPass | Gyrus ACMI, LLC | 2016-10-12 |
| 00821925035393 | UroPass | Gyrus ACMI, LLC | 2016-10-12 |
| 00821925035331 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035461 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035454 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035447 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035430 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035416 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035386 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035379 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035362 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035355 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035348 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035324 | GYRUS ACMI, INC | Gyrus ACMI, LLC | 2016-10-03 |
| 00821925035317 | UroPass | Gyrus ACMI, LLC | 2016-10-03 |
| 00607915111663 | Acucise® Endopyelotomy System | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 10884521007819 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
| 00801741052521 | Bard® Drainage Protector and Catheter Plug | C. R. Bard, Inc. | 2016-09-06 |
| 00607915113858 | UroWire® Guidewire with SL-6® Hydrophilic Coating | APPLIED MEDICAL RESOURCES CORPORATION | 2016-08-18 |
| 00607915113834 | UroWire® Guidewire with SL-6® Hydrophilic Coating | APPLIED MEDICAL RESOURCES CORPORATION | 2016-08-18 |
| 20607915128214 | ACUCISE® PROCEDURAL PACK DELUXE STARTER PACK | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128207 | ACUCISE® PROCEDURAL PACK FEMALE PACK C | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128184 | ACUCISE® PROCEDURAL PACK FEMALE PACK A | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128177 | ACUCISE® PROCEDURAL PACK | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128160 | ACUCISE® PROCEDURAL PACK | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128153 | ACUCISE® PROCEDURAL PACK UNIVERSAL PACK D | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |