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
154d
Avg (2y)
1976
Since
2657 Gastroenterology & Urology devices
Cleared
Mar 27, 1989
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
FJS
Catheter, Peritoneal, Long-term Indwelling
67d
Cleared
Feb 27, 1989
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
KNW
Instrument, Biopsy
76d
Cleared
Feb 13, 1989
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
FFK
Lithotriptor, Electro-hydraulic
200d
Cleared
Feb 08, 1989
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
FKP
System, Dialysate Delivery, Single Patient
198d
Cleared
Feb 08, 1989
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
16d
Cleared
Feb 01, 1989
MICROVASIVE GOLD PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
62d
Cleared
Jan 31, 1989
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
FKX
System, Peritoneal, Automatic Delivery
92d
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
OLYMPUS GF-UM3/EU-M3
GDB
Endoscope, Fiber Optic
183d
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
Jun 20, 1988
DENVER PLEURO-PERITONEAL SHUNT
KPM
Shunt, Peritoneal
131d
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