510(k) K153625 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Single Use Injector NM600/610
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Feb 12, 2016 |
| Received | Dec 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.