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
5365 Gastroenterology & Urology devices
Cleared
Nov 22, 2017
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
GBM
Catheter, Urethral
117d
Cleared
Nov 17, 2017
Gastric Sizing Balloon Catheter
KNT
Tubes, Gastrointestinal (and Accessories)
23d
Cleared
Nov 17, 2017
Single Use Electrosurgical knife
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
211d
Cleared
Nov 15, 2017
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
FAD
Stent, Ureteral
282d
Cleared
Nov 07, 2017
NCompass Nitinol Stone Extractors
LQR
Dislodger, Stone, Biliary
41d
Cleared
Nov 02, 2017
BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
FAD
Stent, Ureteral
262d
Cleared
Nov 02, 2017
BD Curve Ascites Shunt
KPM
Shunt, Peritoneal
265d
Cleared
Oct 27, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
28d
Cleared
Oct 19, 2017
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
LJE
Catheter, Nephrostomy
59d
Cleared
Oct 17, 2017
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
29d
Cleared
Oct 13, 2017
Single Use Hot Biopsy Forceps FD-231
KGE
Forceps, Biopsy, Electric
109d
Cleared
Oct 13, 2017
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
140d
Cleared
Oct 05, 2017
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
KNW
Instrument, Biopsy
42d
Cleared
Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
44d
Cleared
Sep 29, 2017
Endoscopic Ultrasound Aspiration Needle
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
60d
Cleared
Sep 28, 2017
Resection Electrodes with HF cable
FAS
Electrode, Electrosurgical, Active, Urological
90d
Cleared
Sep 20, 2017
Magic3 Go Intermittent Urinary Catheter
EZD
Catheter, Straight
56d
Cleared
Sep 20, 2017
Tri-Ex Extraction Balloon With Multiple Sizing
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
232d
Cleared
Sep 15, 2017
Fresenius Liberty Select Cycler
FKX
System, Peritoneal, Automatic Delivery
102d
Cleared
Sep 14, 2017
Bard Mission Disposable Core Biopsy Instrument
KNW
Instrument, Biopsy
77d
Cleared
Sep 14, 2017
Entuit Start Initial Placement Gastrostomy Set
KGC
Tube, Gastro-enterostomy
225d
Cleared
Sep 11, 2017
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
KNW
Instrument, Biopsy
109d
Cleared
Sep 11, 2017
Navina Classic System
KNT
Tubes, Gastrointestinal (and Accessories)
206d
Cleared
Sep 01, 2017
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
220d
Cleared
Aug 28, 2017
Salle Intraoperative Pyeloplasty Stent Set
FAD
Stent, Ureteral
237d
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