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
8435 Gastroenterology & Urology devices
Cleared
Jan 07, 2000
AUTOMATED CORE BIOPSY DEVICE
KNW
Instrument, Biopsy
18d
Cleared
Jan 06, 2000
MEDISYSTEMS BUTTONHOLE NEEDLE SETS
FIE
Needle, Fistula
302d
Cleared
Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Jan 06, 2000
DISPOS-A-SCOPE
FER
Anoscope And Accessories
63d
Cleared
Jan 06, 2000
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
OCX
Endoscopic Irrigation/suction System
59d
Cleared
Jan 06, 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
FGE
Stents, Drains And Dilators For The Biliary Ducts
51d
Cleared
Dec 30, 1999
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
94d
Cleared
Dec 28, 1999
URETERAL ACCESS SHEATH SET - NEW MODELS
FED
Endoscopic Access Overtube, Gastroenterology-urology
60d
Cleared
Dec 27, 1999
ELITE CUSTOM
LKY
Device, External Penile Rigidity
97d
Cleared
Dec 27, 1999
VITALITY SYSTEM
LKY
Device, External Penile Rigidity
97d
Cleared
Dec 27, 1999
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE
KNW
Instrument, Biopsy
38d
Cleared
Dec 27, 1999
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
18d
Cleared
Dec 23, 1999
DUCPREP BREAST ASPIRATOR, MODEL PMPO2
KNW
Instrument, Biopsy
79d
Cleared
Dec 23, 1999
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
GBM
Catheter, Urethral
55d
Cleared
Dec 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
21d
Cleared
Dec 22, 1999
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
KGE
Forceps, Biopsy, Electric
156d
Cleared
Dec 22, 1999
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
156d
Cleared
Dec 22, 1999
SPACE-OR RETRACTOR
FFO
Retractor, Self-retaining
64d
Cleared
Dec 17, 1999
BIOTEQUE A.V. FISTULA NEEDLE SET
FIE
Needle, Fistula
88d
Cleared
Dec 15, 1999
TRIP TONOMETRY CATHETER, 14F
KNT
Tubes, Gastrointestinal (and Accessories)
75d
Cleared
Dec 15, 1999
AED CYSTOSCOPE
FAJ
Cystoscope And Accessories, Flexible/rigid
44d
Cleared
Dec 10, 1999
CUSTODIOL
KDN
System, Perfusion, Kidney
163d
Cleared
Dec 10, 1999
ENDOSCOPES,10MM DIAMETER 0 DEGREES
GCM
Endoscope, Rigid
85d
Cleared
Dec 10, 1999
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
EZD
Catheter, Straight
74d
Cleared
Dec 10, 1999
BARDEX I.C. PEDIATRIC FOLEY CATHETER
MJC
Catheter, Urological (antimicrobial) And Accessories
58d
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