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
8453 Gastroenterology & Urology devices
Cleared
Jan 24, 1997
A LITHOTRIPTER-COMPATIBLE BASKET
LQC
Lithotriptor, Biliary Mechanical
45d
Cleared
Jan 17, 1997
PRESCOTT'S LIGHT SOURCE MODEL NO. II-150
FCW
Light Source, Fiberoptic, Routine
63d
Cleared
Jan 16, 1997
PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
HIR
Perineometer
346d
Cleared
Jan 10, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
415d
Cleared
Jan 10, 1997
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
EXI
Device, Paste-on For Incontinence, Sterile
100d
Cleared
Jan 10, 1997
CAP-AID (IMPROVED)
FHA
Clamp, Penile
56d
Cleared
Jan 08, 1997
CELL RECOVERY SYSTEM
FDX
Endoscopic Cytology Brush
22d
Cleared
Jan 03, 1997
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
FAM
Sigmoidoscope And Accessories, Flexible/rigid
65d
Cleared
Jan 03, 1997
TZ
KNW
Instrument, Biopsy
37d
Cleared
Dec 30, 1996
INJECTO FLUSH
FCL
Forceps, Biopsy, Non-electric
76d
Cleared
Dec 27, 1996
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
193d
Cleared
Dec 23, 1996
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
OCX
Endoscopic Irrigation/suction System
63d
Cleared
Dec 20, 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
FBO
Cystourethroscope
178d
Cleared
Dec 20, 1996
AUTO SUTURE* ABBI* SYSTEM
KNW
Instrument, Biopsy
87d
Cleared
Dec 17, 1996
BARD COAGULATING RESECTOR MODEL (3552XX
FAS
Electrode, Electrosurgical, Active, Urological
172d
Cleared
Dec 17, 1996
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
74d
Cleared
Dec 16, 1996
ISLAND BIOSURGICAL BOLSTER
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
340d
Cleared
Dec 16, 1996
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
FAM
Sigmoidoscope And Accessories, Flexible/rigid
66d
Cleared
Dec 16, 1996
LITHOVAC SUCTION/ASPIRATION PROBE
KQT
Evacuator, Gastro-urology
62d
Cleared
Dec 13, 1996
KARL STORZ FRIMBERGER VARIOGUIDE
FDT
Duodenoscope And Accessories, Flexible/rigid
186d
Cleared
Dec 13, 1996
MANAN D BAG
EXF
Bag, Bile Collecting
79d
Cleared
Dec 13, 1996
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
56d
Cleared
Dec 12, 1996
COURIER BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
87d
Cleared
Dec 11, 1996
OES UROLOGY
EZO
Urethrotome
664d
Cleared
Dec 10, 1996
ACTIS (VENOUS FLOW CONTROLLER)
LKY
Device, External Penile Rigidity
137d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices