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
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 8 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 7 |
| FEB | Accessories, Cleaning, For Endoscope | 3 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 |
| HIH | Hysteroscope (And Accessories) | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 |
| FBO | Cystourethroscope | 1 |
| FCB | Bag, Hemostatic | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| PSV | Ultrasound Bronchoscope | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Mini Open, Classified |
FEB | K120357 |
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Pro Open, Classified |
FEB | K103264 |
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Elite Open, Classified |
FEB | K201920 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | K131780 |
| Nov 17, 2023 | Aizu 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 |
FGB | K172246 K181451 |
| Nov 17, 2023 | Aizu 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 |
FCB | K172298 |
| Nov 17, 2023 | Aizu 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 |
FET | K143153 K193182 +1 |
| Nov 17, 2023 | Aizu 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 |
FBN | K093507 |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach.
Model Number: PEF-V. Open, Classified |
EOQ | K981543 |
| Nov 17, 2023 | Aizu 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 |
NWB | K071254 |
| Nov 17, 2023 | Aizu 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 |
NWB | K980465 |
| Nov 17, 2023 | Aizu 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 |
NWB | K131780 K192793 +1 |
| Nov 17, 2023 | Aizu 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 |
EOQ | K082720 K201300 |
| Nov 17, 2023 | Aizu 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 |
EOQ | K221631 |
| Nov 17, 2023 | Aizu 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 |
EOQ | K981543 |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Hysterofiberscope-For endoscopic diagnosis within the uterus.
Model Number: HYF-XP. Open, Classified |
EOQ | K963033 |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Hysterovideoscope-For endoscopic diagnosis within the uterus
Model Number: HYF-V. Open, Classified |
HIH | K221557 |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Hysteroscope-For endoscopic diagnosis within the uterus
Model Number: HYF-1T. Open, Classified |
HIH | K891451 |
| Nov 17, 2023 | Aizu 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 |
FDF | K011151 K051645 +4 |
| Nov 17, 2023 | Aizu 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 |
ITX | K011314 K051541 +1 |
| Nov 17, 2023 | Aizu 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 |
EOQ | K061313 K183416 +1 |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney
Model Numbers: CYF-5, CYF-VH, CYF-VHR. Open, Classified |
FAJ | K221683 K221690 |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. Open, Classified |
FBO | K843084 K904799 +1 |
| Nov 17, 2023 | Aizu 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 |
FET | K001241 K051645 +4 |
| Nov 17, 2023 | Aizu 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 |
PSV | K070983 K183525 |
| Nov 17, 2023 | Aizu 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 |
EOQ | K023984 K033225 +4 |
| Jul 20, 2022 | Aizu Olympus Co., Ltd. EVIS EXERA III Bronchovideoscope Terminated |
EOQ | K201758 |