FDA 510(k) Gastroenterology & Urology Devices
FDA 510(k) Gastroenterology & Urology Devices - Regulatory Overview
FDA 510(k) gastroenterology and urology devices cover diagnostic and interventional equipment for the GI tract and urinary system. The FDA review panel code is GU.
Common device types:
- GI endoscopes - gastroscopes, colonoscopes, duodenoscopes and capsule endoscopy
- Biliary and pancreatic stents - metal and plastic biliary drainage devices
- Urological devices - ureteral stents, catheters, stone retrieval baskets
- Ablation systems - RFA and cryoablation for GI lesions
- Anorectal devices - manometry systems, hemorrhoid treatment
9843
Total
9796
Cleared
153d
Avg (2y)
1976
Since
2371 Gastroenterology & Urology devices
Cleared
Jan 30, 1989
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
81d
Cleared
Jan 13, 1989
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
KNW
Instrument, Biopsy
51d
Cleared
Jan 06, 1989
BARD(R) ASPIRATION BIOPSY SYSTEM
KNW
Instrument, Biopsy
144d
Cleared
Dec 22, 1988
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
KNT
Tubes, Gastrointestinal (and Accessories)
71d
Cleared
Nov 15, 1988
BARD(R) URETERAL STENT W/SUTURE
FAD
Stent, Ureteral
88d
Cleared
Oct 25, 1988
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION
OCX
Endoscopic Irrigation/suction System
90d
Cleared
Oct 21, 1988
BARD URETEROSCOPIC DEVICE
FGB
Ureteroscope And Accessories, Flexible/rigid
88d
Cleared
Oct 21, 1988
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
81d
Cleared
Oct 21, 1988
CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100
FJI
Dialyzer, Capillary, Hollow Fiber
64d
Cleared
Oct 21, 1988
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170
FJI
Dialyzer, Capillary, Hollow Fiber
57d
Cleared
Sep 29, 1988
BARD BIOPSY NEEDLE GUIDANCE DEVICE
KNW
Instrument, Biopsy
51d
Cleared
Sep 12, 1988
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
FER
Anoscope And Accessories
158d
Cleared
Aug 02, 1988
CATHETER STRAP
KOD
Catheter, Urological
98d
Cleared
Jul 22, 1988
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
FJI
Dialyzer, Capillary, Hollow Fiber
23d
Cleared
Jul 13, 1988
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
29d
Cleared
Jul 13, 1988
EXTENDED LIFE CAPD TRANSFER SET 5C4444
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
26d
Cleared
May 26, 1988
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
135d
Cleared
May 06, 1988
BARD (R) ESKA ERECTIOMETER
LIL
Monitor, Penile Tumescence
65d
Cleared
Apr 27, 1988
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
29d
Cleared
Jan 29, 1988
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
KPF
System, Dialysate Delivery, Semi-automatic, Peritoneal
119d
Cleared
Jan 29, 1988
CAPILLARY FLOW DIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
72d
Cleared
Oct 20, 1987
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
20d
Cleared
Oct 13, 1987
HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
FII
System, Dialysate Delivery, Sealed
117d
Cleared
Sep 30, 1987
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
FKX
System, Peritoneal, Automatic Delivery
85d
Cleared
Aug 26, 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
106d
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