Company ยท US
Aomori Olympus Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2005. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
113recalls (0 in 12 months)
106recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGX | Snare, Non-Electrical | 39 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 20 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 15 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 10 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 9 |
| FCG | Biopsy Needle | 5 |
| GAA | Needle, Aspiration And Injection, Disposable | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| FAS | Electrode, Electrosurgical, Active, Urological | 4 |
| LFL | Instrument, Ultrasonic Surgical | 4 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 2 |
| LQC | Lithotriptor, Biliary Mechanical | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2005 | K042160 | SONOSURG TROCAR Aomori Olympus Co., Ltd. | LFL |
| Sep 8, 2004 | K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM Aomori Olympus Co., Ltd. | LFL |
| Nov 14, 2003 | K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B Aomori Olympus Co., Ltd. | FGE |
| Oct 1, 2003 | K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM Aomori Olympus Co., Ltd. | LFL |
| Aug 29, 2003 | K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM Aomori Olympus Co., Ltd. | LFL |
| Apr 16, 2003 | K021672 | PANCREATIC DRAINAGE TUBE Aomori Olympus Co., Ltd. | FGE |
| Mar 28, 2003 | K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C Aomori Olympus Co., Ltd. | EOQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2023 | Aomori Olympus Co., Ltd. Reusable distal attachments
Models:
MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290 Open, Classified |
FDS | K984358 |
| Sep 7, 2023 | Aomori Olympus Co., Ltd. Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.
Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012 Open, Classified |
FDS | K984358 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
GEI | K902735 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
GEI | K902735 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of Terminated |
FCG | K023272 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter. Terminated |
LQC | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter. Terminated |
LQC | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Terminated |
FGE | K933200 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Terminated |
FGE | K933200 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Terminated |
FGE | K933200 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. Terminated |
FGE | K933200 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and ext Terminated |
FCG | K050503 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural les Terminated |
FCG | K050503 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesio Terminated |
FCG | K050503 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions Terminated |
FCG | K050503 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
EOQ | K060243 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
EOQ | K060243 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
EOQ | K060243 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
EOQ | K060243 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. Terminated |
FBK | K153625 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal Terminated |
FGX | K172734 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal Terminated |
FGX | K172734 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal Terminated |
FGX | K172734 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal Terminated |
FGX | K172734 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal Terminated |
FGX | K172734 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal Terminated |
FGX | K172734 |
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