KNY · Class II · 21 CFR 876.5130

FDA Product Code KNY: Accessories, Catheter, G-u

Leading manufacturers include Lake Region Mfg., Inc., Promepla Sam and Solace Therapeutics.

65
Total
65
Cleared
105d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 139d recently vs 104d historically

FDA 510(k) Cleared Accessories, Catheter, G-u Devices (Product Code KNY)

65 devices
1–24 of 65
Cleared Aug 05, 2026
Transurethral Catheter Safety Valve (TUCSV) (80050)
K260919
Class Medical , Ltd.
Gastroenterology & Urology · 139d
Cleared Sep 07, 2018
Bi-Flex Evo
K182144
Promepla Sam
Gastroenterology & Urology · 30d
Cleared Mar 02, 2017
Vesair Cystoscopic Sheath
K162356
Solace Therapeutics
Gastroenterology & Urology · 191d
Cleared Jun 17, 2014
BI-FLEX URETERAL ACCESS SHEATH
K140441
Promepla Sam
Gastroenterology & Urology · 116d
Cleared Jun 16, 2014
WIJAY EZ-VOID EXTERNAL CATHETER VALVE
K140562
Leomed, LLC
Gastroenterology & Urology · 103d
Cleared Jun 09, 2014
GUARDIAN URETHRAL SHEATH
K141252
Solace Therapeutics
Gastroenterology & Urology · 26d
Cleared Aug 20, 2013
GUARDIAN URETHRAL SHEATH
K131803
Solace Therapeutics
Gastroenterology & Urology · 62d
Cleared Feb 04, 2013
VARI-PASS VARIABLE LENGTH ACCESS SHEATH
K123170
Olympus Surgical Technologies America
Gastroenterology & Urology · 118d
Cleared May 14, 2012
ROCAMED ROCAUS PLATINUM
K120160
Promepla Sam
Gastroenterology & Urology · 116d
Cleared Sep 08, 2011
PREFILLED CATHETER INFLATION SYRINGE
K112209
Avail Medical Products, Inc.
Gastroenterology & Urology · 38d
Cleared Dec 12, 2006
CYSTOGLIDE INTRODUCER SHEATH
K052298
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 476d
Cleared Oct 16, 2006
CAREVENT
K062240
Chief Medical, LLC
Gastroenterology & Urology · 75d
Cleared May 14, 2006
CATHASSIST
K052952
Physician Technologies, Inc.
Gastroenterology & Urology · 206d
Cleared Sep 22, 2005
CYSTOGLIDE DILATING INTRODUCER SHEATH
K052134
Percutaneous Systems, Inc.
Gastroenterology & Urology · 48d
Cleared Sep 02, 2005
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
K051593
Acmi Corporation
Gastroenterology & Urology · 78d
Cleared Feb 01, 2005
UPDATED SLIP UROLOGY INTRODUCER SHEATH
K042531
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 137d
Cleared Nov 16, 2004
MICROVERTER URETERAL ACCESS SHEATH
K042877
Percutaneous Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 23, 1999
PBN DRAINAGE CATHETER GUIDEWIRES
K991097
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Jul 30, 1998
SNAP-N-PEEL INTRODUCERS
K981611
Circon Corp.
Gastroenterology & Urology · 85d
Cleared Jun 05, 1998
HYDROPHILIC COATED GUIDEWIRE
K981667
Lake Region Mfg., Inc.
Gastroenterology & Urology · 25d
Cleared Apr 22, 1998
MANAN MANTA CATHETER FIXATION DISK
K981229
Medical Device Technologies, Inc.
Gastroenterology & Urology · 19d
Cleared Oct 10, 1997
INSULATOR WIRE GUIDE
K972977
Cook Urological, Inc.
Gastroenterology & Urology · 60d
Cleared Apr 05, 1996
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
K960866
Lake Region Mfg., Inc.
Gastroenterology & Urology · 32d
Cleared Mar 26, 1996
MANAN MANTA CATHETER FIXATION DISK
K954132
Manan Medical Products, Inc.
Gastroenterology & Urology · 207d

About Product Code KNY - Regulatory Context

510(k) Submission Activity

65 total 510(k) submissions under product code KNY since 1976, with 65 receiving FDA clearance (average review time: 105 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KNY Product Code

Recent submissions under KNY have taken an average of 139 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.

KNY devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →