ClearanceBrief
Company ยท US

Aizu Olympus Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2005. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
31recalls (3 in 12 months)
31recalls that name a 510(k)

Product codes

CodeDeviceRecords
EOQBronchoscope (Flexible Or Rigid)8
FDFColonoscope And Accessories, Flexible/Rigid7
FEBAccessories, Cleaning, For Endoscope3
NWBEndoscope, Accessories, Narrow Band Spectrum3
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology2
HIHHysteroscope (And Accessories)2
FAJCystoscope And Accessories, Flexible/Rigid1
FBNCholedochoscope And Accessories, Flexible/Rigid1
FBOCystourethroscope1
FCBBag, Hemostatic1
FGBUreteroscope And Accessories, Flexible/Rigid1
ITXTransducer, Ultrasonic, Diagnostic1
PSVUltrasound Bronchoscope1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 28, 2005K043487EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
Aizu Olympus Co., Ltd.
FDF

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 2, 2025Aizu Olympus Co., Ltd.
Olympus OER-Mini
Open, Classified
FEBK120357
Dec 2, 2025Aizu Olympus Co., Ltd.
Olympus OER-Pro
Open, Classified
FEBK103264
Dec 2, 2025Aizu Olympus Co., Ltd.
Olympus OER-Elite
Open, Classified
FEBK201920
Nov 29, 2023Aizu Olympus Co., Ltd.
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Open, Classified
FDFK131780
Nov 29, 2023Aizu Olympus Co., Ltd.
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Open, Classified
FDFK131780
Nov 29, 2023Aizu Olympus Co., Ltd.
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Open, Classified
FDFK131780
Nov 29, 2023Aizu Olympus Co., Ltd.
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Open, Classified
FDFK131780
Nov 29, 2023Aizu Olympus Co., Ltd.
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Open, Classified
FDFK131780
Nov 17, 2023Aizu Olympus Co., Ltd.
Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
Open, Classified
FGBK172246
K181451
Nov 17, 2023Aizu Olympus Co., Ltd.
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
Open, Classified
FCBK172298
Nov 17, 2023Aizu Olympus Co., Ltd.
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.
Open, Classified
FETK143153
K193182 +1
Nov 17, 2023Aizu Olympus Co., Ltd.
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Numb
Open, Classified
FBNK093507
Nov 17, 2023Aizu Olympus Co., Ltd.
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
Open, Classified
EOQK981543
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 17, 2023Aizu Olympus Co., Ltd.
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Open, Classified
EOQK082720
K201300
Nov 17, 2023Aizu Olympus Co., Ltd.
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
Open, Classified
EOQK221631
Nov 17, 2023Aizu Olympus Co., Ltd.
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
Open, Classified
EOQK981543
Nov 17, 2023Aizu Olympus Co., Ltd.
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Open, Classified
EOQK963033
Nov 17, 2023Aizu Olympus Co., Ltd.
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Open, Classified
HIHK221557
Nov 17, 2023Aizu Olympus Co., Ltd.
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
Open, Classified
HIHK891451
Nov 17, 2023Aizu Olympus Co., Ltd.
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170
Open, Classified
FDFK011151
K051645 +4
Nov 17, 2023Aizu Olympus Co., Ltd.
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
Open, Classified
ITXK011314
K051541 +1
Nov 17, 2023Aizu Olympus Co., Ltd.
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
Open, Classified
EOQK061313
K183416 +1
Nov 17, 2023Aizu Olympus Co., Ltd.
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
Open, Classified
FAJK221683
K221690
Nov 17, 2023Aizu Olympus Co., Ltd.
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Open, Classified
FBOK843084
K904799 +1
Nov 17, 2023Aizu Olympus Co., Ltd.
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170
Open, Classified
FETK001241
K051645 +4
Nov 17, 2023Aizu Olympus Co., Ltd.
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrou
Open, Classified
PSVK070983
K183525
Nov 17, 2023Aizu Olympus Co., Ltd.
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60
Open, Classified
EOQK023984
K033225 +4
Jul 20, 2022Aizu Olympus Co., Ltd.
EVIS EXERA III Bronchovideoscope
Terminated
EOQK201758
Get alerts for these product codes