Gastroenterology & Urology

FDA medical specialty panel: Gastroenterology & Urology. Product code prefix: GU.

44 companies · 368 devices
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368 devices

Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616)

Class Class II K223616 ODG
2022-12-30

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (K223295)

Class Class II K223295 FDA
2023-01-11

HandX Instrument – Monopolar Spatula (K222011)

Class Class II K222011 GCJ
2023-01-12

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (K221020)

Class Class II K221020 EZL
2023-01-13

Scivita 4KINSIGHT ICG Imaging System (K221252)

Class Class II K221252 GCJ
2023-01-13

Vibrant System (K223031)

Class Class II K223031 QTN
2023-01-13

Power Acute Triple Lumen Hemodialysis Catheter (K222170)

Class Class II K222170 NIE
2023-01-13

Disposable Endoscope Valve Sets (K220884)

Class Class II K220884 ODC
2023-01-17

Transit-Pellets (K222000)

Class Class II K222000 FFX
2023-01-18

MultiCut Solo (K213597)

Class Class II K213597 GCJ
2023-01-18

LM-9300 Plus Lithotripter (K213772)

Class Class II K213772 LNS
2023-01-19

Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) (K222462)

Class Class II K222462 KNW
2023-01-20

CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) (K221683)

Class Class II K221683 FAJ
2023-01-20

FUJIFILM Endoscope Model EI-740D/S (K221551)

Class Class II K221551 FDS
2023-01-27

StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring (K221515)

Class Class II K221515 FGB
2023-02-02

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH (K221781)

Class Class II K221781 GCJ
2023-02-02

hygh-tec drainage (K221400)

Class Class II K221400 KNT
2023-02-09

ETHICON LINX® Esophagus Sizing Tool (K230089)

Class Class II K230089 QJN
2023-02-09

DiLumen C1, EZ1 and Tool Mount (K221452)

Class Class II K221452 FDF
2023-02-10

AmeriWater MediQA Reverse Osmosis System (MSP3HF) (K223656)

Class Class II K223656 FIP
2023-02-13

ReShape Calibration Tubes (K230131)

Class Class II K230131 KNT
2023-02-15

Single-use Video Pancreaticobiliary Scope, PB Digital Controller (K221784)

Class Class II K221784 FBN
2023-02-16

troCarWash™ System (K222695)

Class Class II K222695 OCX
2023-02-17

FloNavi Endoscopic Fluorescence Imaging System (K221861)

Class Class II K221861 GCJ
2023-02-18
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