Product code KNY— Gastroenterology, Urology
GUARDIAN URETHRAL SHEATH
- Classification name
- Accessories, Catheter, G-U
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 65
- First cleared
- Most recent
Market context for product code KNY
FDA has cleared devices under product code KNY between 1976 and 2026, filed by 50 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2018
- 2017
- 2014
- 2013
- 2012
- 2011
- 2009
- 2006
- 2005
- 2004
- 2003
- 2000
- 1999
- 1998
Top applicants under product code KNY
Recent clearances under product code KNY
- K260919 — Transurethral Catheter Safety Valve (TUCSV) (80050)
- K182144 — Bi-Flex Evo
- K162356 — Vesair Cystoscopic Sheath
- K140441 — BI-FLEX URETERAL ACCESS SHEATH
- K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE
- K141252 — GUARDIAN URETHRAL SHEATH
- K131803 — GUARDIAN URETHRAL SHEATH
- K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH
- K120160 — ROCAMED ROCAUS PLATINUM
- K112209 — PREFILLED CATHETER INFLATION SYRINGE
- K090121 — PRE-FILLED CATHETER INFLATION SYRINGE
- K052298 — CYSTOGLIDE INTRODUCER SHEATH
- K062240 — CAREVENT
- K052952 — CATHASSIST
- K052134 — CYSTOGLIDE DILATING INTRODUCER SHEATH
- K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 61224
- K042531 — UPDATED SLIP UROLOGY INTRODUCER SHEATH
- K042877 — MICROVERTER URETERAL ACCESS SHEATH
- K040520 — SLIP UROLOGY INTRODUCER SHEATH
- K032127 — HEMEDEX FIXATION DEVICE
- K023690 — CATHETER CONNECTOR
- K000767 — MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
- K991097 — PBN DRAINAGE CATHETER GUIDEWIRES
- K981611 — SNAP-N-PEEL INTRODUCERS
- K981667 — HYDROPHILIC COATED GUIDEWIRE
- K981229 — MANAN MANTA CATHETER FIXATION DISK
- K972977 — INSULATOR WIRE GUIDE
- K960866 — LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
- K954132 — MANAN MANTA CATHETER FIXATION DISK
- K952414 — PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER
- K951995 — KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR
- K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
- K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
- K944754 — AMPLATZ SUPER STIFF GUIDEWIRE
- K944135 — UROLOGICAL GUIDWIRE
- K934072 — CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
- K942205 — ZEBRA UROLOGICAL GUIDEWIRE
- K942074 — FLEXFINDER GUIDEWIRE
- K935643 — SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE
- K932143 — FLEXI-TRAK ANCHORING DEVICE
- K931013 — FOLEY CATHETER TRAY
- K926039 — GUIDE-TECH ENCAPSULATED GUIDEWIRE
- K925161 — NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
- K923496 — URINARY CARE SUPPLIES
- K925281 — KIT PAK URINARY CARE SUPPLIES
- K926344 — HYDROPHILIC COATED GUIDEWIRE
- K921200 — GUIDEWIRE
- K921055 — KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
- K912919 — MENTOR INFUSION LINE
- K914211 — CATH CONTROL
- K913679 — UNIVERSAL SWIVEL PATCH
- K912146 — URETERAL CATHETER HOLDER
- K905128 — FLEXI-TRAK(TM) ANCHORING DEVICE
- K900031 — MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
- K896806 — CATHETER PLUG/PROTECTOR
- K890072 — PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
- K884819 — O'NEIL URINARY CATHETER INTRODUCER
- K881878 — CATHETER WITHDRAWAL UNIT
- K882641 — TECNOL CATHETER LEG STRAP
- K873288 — CLOSED FOLEY CATHETER SYSTEM
- K833242 — DEFLECTING GUIDE WIRE
- K821336 — TRANSENDOSCOPIC INJECTION CATHETER TEI
- K781987 — URINARY DRAINAGE BAG
- K771212 — SAFEED DISP. PLASTIC CATHETER
- K760943 — SILASTIC BRAND GASTRIC LAVAGE TUBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.