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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5375 Gastroenterology & Urology devices
Cleared
May 08, 1992
ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
FRQ
Tube, Levine
191d
Cleared
May 06, 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
KOE
Dilator, Urethral
78d
Cleared
May 06, 1992
DOBBHOFF BIPOLAR ADAPTER
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
64d
Cleared
Apr 27, 1992
BARD 4-WIRE URETEROSCOPIC STONE
FFL
Dislodger, Stone, Basket, Ureteral, Metal
45d
Cleared
Apr 23, 1992
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
LFK
Catheter, Femoral
171d
Cleared
Apr 16, 1992
BARD URETEROSCOPE DEFLECTION MODULE
FGB
Ureteroscope And Accessories, Flexible/rigid
57d
Cleared
Apr 14, 1992
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
KNT
Tubes, Gastrointestinal (and Accessories)
153d
Cleared
Apr 10, 1992
AKCESS-CATH KIT
LFJ
Catheter, Subclavian
168d
Cleared
Apr 09, 1992
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
LIF
Dialyzer Reprocessing System
209d
Cleared
Mar 31, 1992
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
KOC
Accessories, Blood Circuit, Hemodialysis
307d
Cleared
Mar 31, 1992
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
126d
Cleared
Mar 30, 1992
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
160d
Cleared
Mar 27, 1992
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
LFK
Catheter, Femoral
130d
Cleared
Mar 20, 1992
ENTRAC(TM) URETHRAL MEASURING CATHETER
GBM
Catheter, Urethral
140d
Cleared
Mar 18, 1992
AMS SPHINCTER 800 URINARY PROSTHESIS
FAG
Prosthesis, Urethral Sphincter
257d
Cleared
Mar 18, 1992
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
FAE
Prosthesis, Penile
257d
Cleared
Mar 18, 1992
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
EZN
Dilator, Catheter, Ureteral
110d
Cleared
Mar 16, 1992
PERITONEAL DIALYSIS CYCLER SET
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
167d
Cleared
Mar 16, 1992
DEXTROLYTE II PERITONEAL DIALYSIS PUMP
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
90d
Cleared
Mar 11, 1992
BIPOLAR ENDOSTASIS PROBE, BEST (TM)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
100d
Cleared
Mar 11, 1992
ACKRAD ERCP CONTRAST DELIVERY SET
FGE
Stents, Drains And Dilators For The Biliary Ducts
72d
Cleared
Mar 06, 1992
SAECG CARDIOGRAPH MODEL M1754A
KNT
Tubes, Gastrointestinal (and Accessories)
182d
Cleared
Mar 06, 1992
NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
157d
Cleared
Mar 06, 1992
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
88d
Cleared
Feb 25, 1992
NMC CYCLER MACHINE
FKX
System, Peritoneal, Automatic Delivery
425d
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