FDA Product Code
FDA Product Code KNY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical , Ltd. | 2026-08-05 | Traditional | PDF ↗ |
| K182144 | Bi-Flex Evo | Promepla Sam | 2018-09-07 | Special | PDF ↗ |
| K162356 | Vesair Cystoscopic Sheath | Solace Therapeutics | 2017-03-02 | Special | PDF ↗ |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | Promepla Sam | 2014-06-17 | Traditional | PDF ↗ |
| K140562 | WIJAY EZ-VOID EXTERNAL CATHETER VALVE | Leomed, LLC | 2014-06-16 | Traditional | PDF ↗ |
| K141252 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2014-06-09 | Special | PDF ↗ |
| K131803 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2013-08-20 | Special | PDF ↗ |
| K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH | Olympus Surgical Technologies America | 2013-02-04 | Special | PDF ↗ |
| K120160 | ROCAMED ROCAUS PLATINUM | Promepla Sam | 2012-05-14 | Traditional | PDF ↗ |
| K112209 | PREFILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2011-09-08 | Special | PDF ↗ |
| K090121 | PRE-FILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2009-04-15 | Special | PDF ↗ |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2006-12-12 | Traditional | PDF ↗ |
| K062240 | CAREVENT | Chief Medical, LLC | 2006-10-16 | Traditional | PDF ↗ |
| K052952 | CATHASSIST | Physician Technologies, Inc. | 2006-05-14 | Traditional | PDF ↗ |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2005-09-22 | Traditional | PDF ↗ |
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | Acmi Corporation | 2005-09-02 | Traditional | PDF ↗ |
| K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2005-02-01 | Special | PDF ↗ |
| K042877 | MICROVERTER URETERAL ACCESS SHEATH | Percutaneous Systems, Inc. | 2004-11-16 | Traditional | PDF ↗ |
| K040520 | SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2004-05-20 | Traditional | PDF ↗ |
| K032127 | HEMEDEX FIXATION DEVICE | Hemedex Incorporated | 2003-12-30 | Traditional | PDF ↗ |
| K023690 | CATHETER CONNECTOR | World Metals, Inc. | 2003-02-28 | Traditional | PDF ↗ |
| K000767 | MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 | Memcath Technologies, LLC | 2000-06-05 | Traditional | PDF ↗ |
| K991097 | PBN DRAINAGE CATHETER GUIDEWIRES | Medical Device Technologies, Inc. | 1999-04-23 | Traditional | PDF ↗ |
| K981611 | SNAP-N-PEEL INTRODUCERS | Circon Corp. | 1998-07-30 | Traditional | PDF ↗ |
| K981667 | HYDROPHILIC COATED GUIDEWIRE | Lake Region Mfg., Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K981229 | MANAN MANTA CATHETER FIXATION DISK | Medical Device Technologies, Inc. | 1998-04-22 | Traditional | PDF ↗ |
| K972977 | INSULATOR WIRE GUIDE | Cook Urological, Inc. | 1997-10-10 | Traditional | PDF ↗ |
| K960866 | LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. | Lake Region Mfg., Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K954132 | MANAN MANTA CATHETER FIXATION DISK | Manan Medical Products, Inc. | 1996-03-26 | Traditional | PDF ↗ |
| K952414 | PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER | Acacia Laboratories, Inc. | 1995-06-23 | Traditional | PDF ↗ |
| K951995 | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR | Karl Storz Endoskop GmbH | 1995-05-24 | Traditional | PDF ↗ |
| K951488 | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP | The Kendal Co. | 1995-04-25 | Traditional | PDF ↗ |
| K943835 | PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID | Orion Life Systems, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K944754 | AMPLATZ SUPER STIFF GUIDEWIRE | Boston Scientific Corp | 1994-10-07 | Traditional | PDF ↗ |
| K944135 | UROLOGICAL GUIDWIRE | Applied Medical Resources | 1994-09-21 | Traditional | PDF ↗ |
| K934072 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM | Contour Fabricators of Florida, Inc. | 1994-09-08 | Traditional | PDF ↗ |
| K942205 | ZEBRA UROLOGICAL GUIDEWIRE | Boston Scientific Corp | 1994-07-07 | Traditional | PDF ↗ |
| K942074 | FLEXFINDER GUIDEWIRE | Flexmedics | 1994-06-24 | Traditional | PDF ↗ |
| K935643 | SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE | Regulatory & Marketing Services, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K932143 | FLEXI-TRAK ANCHORING DEVICE | Convatec, A Division of E.R. Squibb & Sons | 1993-12-01 | Traditional | PDF ↗ |
| K931013 | FOLEY CATHETER TRAY | Kit Pak, Inc. | 1993-08-09 | Traditional | PDF ↗ |
| K926039 | GUIDE-TECH ENCAPSULATED GUIDEWIRE | Cape Tech Medical Products | 1993-08-05 | Traditional | PDF ↗ |
| K925161 | NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO | North American Sterilization & Packaging Co. | 1993-07-21 | Traditional | PDF ↗ |
| K923496 | URINARY CARE SUPPLIES | Orion Life Systems, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K925281 | KIT PAK URINARY CARE SUPPLIES | Kit Pak, Inc. | 1993-04-19 | Traditional | PDF ↗ |
| K926344 | HYDROPHILIC COATED GUIDEWIRE | Surgitek | 1993-03-05 | Traditional | PDF ↗ |
| K921200 | GUIDEWIRE | Lake Region Mfg., Inc. | 1992-09-04 | Traditional | PDF ↗ |
| K921055 | KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1992-05-11 | Traditional | PDF ↗ |
| K912919 | MENTOR INFUSION LINE | Mentor Corp. | 1991-12-13 | Traditional | PDF ↗ |
| K914211 | CATH CONTROL | Highpoint Medical Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K913679 | UNIVERSAL SWIVEL PATCH | Bryman Medical | 1991-09-05 | Traditional | PDF ↗ |
| K912146 | URETERAL CATHETER HOLDER | Inman Liebelt Corp. | 1991-07-26 | Traditional | PDF ↗ |
| K905128 | FLEXI-TRAK(TM) ANCHORING DEVICE | Convatec, A Division of E.R. Squibb & Sons | 1990-11-29 | Traditional | PDF ↗ |
| K900031 | MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS | Porges Corp. | 1990-03-06 | Traditional | PDF ↗ |
| K896806 | CATHETER PLUG/PROTECTOR | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-26 | Traditional | PDF ↗ |
| K890072 | PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE | Medireach, Inc. | 1989-06-12 | Traditional | PDF ↗ |
| K884819 | O'NEIL URINARY CATHETER INTRODUCER | Medical Marketing Group | 1989-02-17 | Traditional | PDF ↗ |
| K881878 | CATHETER WITHDRAWAL UNIT | Eris Medical Technology | 1988-07-28 | Traditional | PDF ↗ |
| K882641 | TECNOL CATHETER LEG STRAP | Tecnol New Jersey Wound Care, Inc. | 1988-07-12 | Traditional | PDF ↗ |
| K873288 | CLOSED FOLEY CATHETER SYSTEM | Todd Medical, Inc. | 1987-11-27 | Traditional | PDF ↗ |
| K833242 | DEFLECTING GUIDE WIRE | Van-Tec, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K821336 | TRANSENDOSCOPIC INJECTION CATHETER TEI | Sounson Research Co., Inc. | 1982-05-21 | Traditional | PDF ↗ |
| K781987 | URINARY DRAINAGE BAG | Kelsar Corp. | 1978-12-04 | Traditional | PDF ↗ |
| K771212 | SAFEED DISP. PLASTIC CATHETER | Terumo America, Inc. | 1977-09-12 | Traditional | PDF ↗ |
| K760943 | SILASTIC BRAND GASTRIC LAVAGE TUBE | Dow Corning Corp. Healthcare Industries Materials | 1976-11-23 | Traditional | PDF ↗ |
Product code KNY · Class II · Gastroenterology, Urology. Data: openFDA.