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Panels › Gastroenterology, Urology › Product code NWB · Class 2

Endoscope, Accessories, Narrow Band Spectrum

Regulation 876.1500

0510(k)s in 12 months (9 all time)
0recalls in 12 months (19 all time)
19recalls that name a 510(k)
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Top companies in NWB

Company510(k)sRecalls
Olympus Corporation of the Americas116
Olympus Medical Systems Corporation40
Aizu Olympus Co., Ltd.03
Sonoscape Medical Corp.30
Olympus Winter & Ibe GmbH10
DateFirm and productCodeLinked 510(k)
Jun 5, 2025Olympus Corporation of the Americas
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Open, Classified		 NWBK220587
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number PCF-Q180AL.
Open, Classified		 NWBK100584
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number PCF-HQ190L.
Open, Classified		 NWBK192793
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number PCF-H190TL.
Open, Classified		 NWBK192793
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number PCF-H190DL.
Open, Classified		 NWBK131780
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number PCF-H180AL.
Open, Classified		 NWBK100584
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number CF-Q180AL.
Open, Classified		 NWBK100584
Feb 29, 2024Olympus Corporation of the Americas
Colonoscope, Model Number CF-H180AL.
Open, Classified		 NWBK100584
Nov 17, 2023Aizu Olympus Co., Ltd.
Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower diges
Open, Classified		 NWBK071254
Nov 17, 2023Aizu Olympus Co., Ltd.
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Open, Classified		 NWBK980465
Nov 17, 2023Aizu Olympus Co., Ltd.
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL,
Open, Classified		 NWBK131780
K192793 +1
Nov 9, 2023Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Open, Classified		 NWBK121959
Nov 9, 2023Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Open, Classified		 NWBK061313
Feb 13, 2023Olympus Corporation of the Americas
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
Open, Classified		 NWBK100584
Mar 25, 2022Olympus Corporation of the Americas
Olympus Uretero-reno videoscope, Model No. URF-V2
Open, Classified		 NWBK172246
Dec 17, 2018Olympus Corporation of the Americas
Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Terminated		 NWBK143153
Dec 17, 2018Olympus Corporation of the Americas
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Terminated		 NWBK100584
Dec 17, 2018Olympus Corporation of the Americas
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Terminated		 NWBK051645
Dec 12, 2016Olympus Corporation of the Americas
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
Terminated		 NWBK072957

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