Medical Device Manufacturer · US , Jeffrey , NH

Rusch Intl. - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1995
43
Total
43
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rusch Intl. Gastroenterology & Urology
20 devices
1-20 of 20
Cleared Dec 23, 2003
INTERMITTENT URETHRAL CATHETERS
K033023 · KOD
Gastroenterology & Urology · 88d
Cleared Jun 30, 2003
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
K030559 · ESW
Gastroenterology & Urology · 129d
Cleared Jun 17, 2003
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
K023666 · FGE
Gastroenterology & Urology · 229d
Cleared Jul 01, 2002
RUSCH FLONEIL
K020714 · GBM
Gastroenterology & Urology · 118d
Cleared Feb 26, 2002
RUSCH MILLER-ABBOTT TUBE
K010797 · KNT
Gastroenterology & Urology · 347d
Cleared Feb 26, 2002
RUSCH CANTOR TUBE
K010798 · KNT
Gastroenterology & Urology · 347d
Cleared Nov 16, 2001
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
K011121 · LJE
Gastroenterology & Urology · 218d
Cleared Feb 08, 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · ESW
Gastroenterology & Urology · 31d
Cleared Feb 18, 2000
FLOCATH
K000070 · KOD
Gastroenterology & Urology · 39d
Cleared Dec 09, 1999
RUSCH BRILLANT SILICONE FOLEY
K993063 · EZL
Gastroenterology & Urology · 87d
Cleared Jul 02, 1999
DD URETERAL STENT, INTEGRAL STENT
K982974 · FAD
Gastroenterology & Urology · 311d
Cleared Feb 12, 1999
SELF CATH SET/SAFETY CATH
K983010 · FCM
Gastroenterology & Urology · 168d
Cleared Jun 05, 1998
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203 · KNT
Gastroenterology & Urology · 64d
Cleared May 18, 1998
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)
K973892 · KNT
Gastroenterology & Urology · 216d
Cleared Jan 08, 1998
RUSCH BRILLANT SILICONE FOLEY CATHETER
K972184 · EZL
Gastroenterology & Urology · 212d
Cleared Oct 07, 1997
RUSCH BRILLANT BALLOON CATHETER
K971643 · EZL
Gastroenterology & Urology · 155d
Cleared Feb 04, 1997
SYMPACATH HYDROGEL COATED FOLEY
K964575 · EZL
Gastroenterology & Urology · 82d
Cleared Aug 27, 1996
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
K962472 · FAP
Gastroenterology & Urology · 63d
Cleared Jun 15, 1995
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
K952573 · FEN
Gastroenterology & Urology · 10d
Cleared Jun 13, 1995
RUSCH INTERNATIONAL URODYNAMIC CATHETERS
K952029 · FEN
Gastroenterology & Urology · 43d
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