Panels › Gastroenterology, Urology › Product code KNY · Class 2
Accessories, Catheter, G-U
Regulation 876.5130
1510(k)s in 12 months (65 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in KNY
| Company | 510(k)s | Recalls |
|---|---|---|
| Percutaneous Systems, Inc. | 5 | 0 |
| Lake Region Mfg., Inc. | 3 | 0 |
| Promepla Sam | 3 | 0 |
| Solace Therapeutics | 3 | 0 |
| Avail Medical Products, Inc. | 2 | 0 |
| Boston Scientific Corp | 2 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 2 | 0 |
| Kit Pak, Inc. | 2 | 0 |
| Medical Device Technologies, Inc. | 2 | 0 |
| Olympus Corporation of the Americas | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2026 | K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) Class Medical , Ltd., IE | KNY |
| Sep 7, 2018 | K182144 | Bi-Flex Evo Promepla Sam, MC | KNY |
| Mar 2, 2017 | K162356 | Vesair Cystoscopic Sheath Solace Therapeutics | KNY |
| Jun 17, 2014 | K140441 | BI-FLEX URETERAL ACCESS SHEATH Promepla Sam, MC | KNY |
| Jun 16, 2014 | K140562 | WIJAY EZ-VOID EXTERNAL CATHETER VALVE Leomed, LLC | KNY |
| Jun 9, 2014 | K141252 | GUARDIAN URETHRAL SHEATH Solace Therapeutics | KNY |
| Aug 20, 2013 | K131803 | GUARDIAN URETHRAL SHEATH Solace Therapeutics | KNY |
| Feb 4, 2013 | K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH Olympus Surgical Technologies America | KNY |
| May 14, 2012 | K120160 | ROCAMED ROCAUS PLATINUM Promepla Sam, MC | KNY |
| Sep 8, 2011 | K112209 | PREFILLED CATHETER INFLATION SYRINGE Avail Medical Products, Inc. | KNY |
| Apr 15, 2009 | K090121 | PRE-FILLED CATHETER INFLATION SYRINGE Avail Medical Products, Inc. | KNY |
| Dec 12, 2006 | K052298 | CYSTOGLIDE INTRODUCER SHEATH Percutaneous Systems, Incorporated | KNY |
| Oct 16, 2006 | K062240 | CAREVENT Chief Medical, LLC | KNY |
| May 14, 2006 | K052952 | CATHASSIST Physician Technologies, Inc. | KNY |
| Sep 22, 2005 | K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH Percutaneous Systems, Inc. | KNY |
| Sep 2, 2005 | K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 Acmi Corporation | KNY |
| Feb 1, 2005 | K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH Percutaneous Systems, Incorporated | KNY |
| Nov 16, 2004 | K042877 | MICROVERTER URETERAL ACCESS SHEATH Percutaneous Systems, Inc. | KNY |
| May 20, 2004 | K040520 | SLIP UROLOGY INTRODUCER SHEATH Percutaneous Systems, Inc. | KNY |
| Dec 30, 2003 | K032127 | HEMEDEX FIXATION DEVICE Hemedex Incorporated | KNY |
| Feb 28, 2003 | K023690 | CATHETER CONNECTOR World Metals, Inc. | KNY |
| Jun 5, 2000 | K000767 | MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 Memcath Technologies, LLC | KNY |
| Apr 23, 1999 | K991097 | PBN DRAINAGE CATHETER GUIDEWIRES Medical Device Technologies, Inc. | KNY |
| Jul 30, 1998 | K981611 | SNAP-N-PEEL INTRODUCERS Circon Corp. | KNY |
| Jun 5, 1998 | K981667 | HYDROPHILIC COATED GUIDEWIRE Lake Region Mfg., Inc. | KNY |
| Apr 22, 1998 | K981229 | MANAN MANTA CATHETER FIXATION DISK Medical Device Technologies, Inc. | KNY |
| Oct 10, 1997 | K972977 | INSULATOR WIRE GUIDE Cook Urological, Inc. | KNY |
| Apr 5, 1996 | K960866 | LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. Lake Region Mfg., Inc. | KNY |
| Mar 26, 1996 | K954132 | MANAN MANTA CATHETER FIXATION DISK Manan Medical Products, Inc. | KNY |
| Jun 23, 1995 | K952414 | PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER Acacia Laboratories, Inc. | KNY |
| May 24, 1995 | K951995 | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR Karl Storz Endoskop GmbH | KNY |
| Apr 25, 1995 | K951488 | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP The Kendal Co. | KNY |
| Jan 24, 1995 | K943835 | PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID Orion Life Systems, Inc. | KNY |
| Oct 7, 1994 | K944754 | AMPLATZ SUPER STIFF GUIDEWIRE Boston Scientific Corp | KNY |
| Sep 21, 1994 | K944135 | UROLOGICAL GUIDWIRE Applied Medical Resources | KNY |
| Sep 8, 1994 | K934072 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM Contour Fabricators of Florida, Inc. | KNY |
| Jul 7, 1994 | K942205 | ZEBRA UROLOGICAL GUIDEWIRE Boston Scientific Corp | KNY |
| Jun 24, 1994 | K942074 | FLEXFINDER GUIDEWIRE Flexmedics | KNY |
| Jun 10, 1994 | K935643 | SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE Regulatory & Marketing Services, Inc. | KNY |
| Dec 1, 1993 | K932143 | FLEXI-TRAK ANCHORING DEVICE Convatec, A Division of E.R. Squibb & Sons | KNY |
| Aug 9, 1993 | K931013 | FOLEY CATHETER TRAY Kit Pak, Inc. | KNY |
| Aug 5, 1993 | K926039 | GUIDE-TECH ENCAPSULATED GUIDEWIRE Cape Tech Medical Products | KNY |
| Jul 21, 1993 | K925161 | NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO North American Sterilization & Packaging Co. | KNY |
| May 27, 1993 | K923496 | URINARY CARE SUPPLIES Orion Life Systems, Inc. | KNY |
| Apr 19, 1993 | K925281 | KIT PAK URINARY CARE SUPPLIES Kit Pak, Inc. | KNY |
| Mar 5, 1993 | K926344 | HYDROPHILIC COATED GUIDEWIRE Surgitek | KNY |
| Sep 4, 1992 | K921200 | GUIDEWIRE Lake Region Mfg., Inc. | KNY |
| May 11, 1992 | K921055 | KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER Kendall Healthcare Products Co. Div.Of Tyco Health | KNY |
| Dec 13, 1991 | K912919 | MENTOR INFUSION LINE Mentor Corp. | KNY |
| Nov 22, 1991 | K914211 | CATH CONTROL Highpoint Medical Corp. | KNY |
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