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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8494 Gastroenterology & Urology devices
Cleared
Dec 17, 1984
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
42d
Cleared
Dec 11, 1984
KARL STORZ 27086KC ULTRASONIC LITHOTRI
FEO
Lithotriptor, Ultrasonic
126d
Cleared
Dec 07, 1984
FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
KNT
Tubes, Gastrointestinal (and Accessories)
43d
Cleared
Dec 05, 1984
PHARMA-PLAST RECTAL TIP
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
90d
Cleared
Dec 05, 1984
PHARMA-PLAST URIDROP-URIDOME
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
90d
Cleared
Dec 05, 1984
PERCUTANEOUS NEPHROSTOMY TROCAR SYS
LJE
Catheter, Nephrostomy
44d
Cleared
Dec 05, 1984
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR
KNT
Tubes, Gastrointestinal (and Accessories)
34d
Cleared
Nov 29, 1984
UNITED SKIN BARRIERS
EXB
Collector, Ostomy
43d
Cleared
Nov 29, 1984
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
EXB
Collector, Ostomy
16d
Cleared
Nov 21, 1984
NORTA SILICONIZED LATEX BALLOON CATH.
KOD
Catheter, Urological
154d
Cleared
Nov 20, 1984
ACCUMETER ELECTRONIC URINEMETER SYSTEM
FFG
Device, Urine Flow Rate Measuring, Non-electrical, Disposable
36d
Cleared
Nov 16, 1984
ASN MONITOR SINGLE NEEDLE MONITOR
KOC
Accessories, Blood Circuit, Hemodialysis
70d
Cleared
Nov 16, 1984
SCD STERILE CONNECTION DEVICE
FKX
System, Peritoneal, Automatic Delivery
24d
Cleared
Oct 24, 1984
MALLEABLE PENILE PROSTHESIS
FAE
Prosthesis, Penile
65d
Cleared
Oct 19, 1984
UROPUMP MODEL 1711
FFG
Device, Urine Flow Rate Measuring, Non-electrical, Disposable
64d
Cleared
Oct 18, 1984
AMER. BENTLEY CONTINU-BLOOD PROCESSOR-
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
184d
Cleared
Oct 18, 1984
INFRARED COAGULATOR
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
92d
Cleared
Oct 18, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
FKX
System, Peritoneal, Automatic Delivery
87d
Cleared
Oct 18, 1984
PHARMA-PLAST CONNECTING TUBE TYPE URIN-
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
42d
Cleared
Oct 18, 1984
AMER. BENTLEY HEMOFILTER HOLDER HFH-1
FKI
Set, Dialyzer Holder
42d
Cleared
Oct 18, 1984
HOLLOW FIBER DIALYZER
KOC
Accessories, Blood Circuit, Hemodialysis
31d
Cleared
Oct 11, 1984
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
KNT
Tubes, Gastrointestinal (and Accessories)
49d
Cleared
Oct 11, 1984
GAUDERER GASTROSTOMY BUTTON
KNT
Tubes, Gastrointestinal (and Accessories)
43d
Cleared
Oct 11, 1984
PHARMA-PLAST LEG BAG
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
35d
Cleared
Oct 11, 1984
PHARMA-PLAST URINARY DRAINAGE BAG 2000
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
35d
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