510(k) K091495 ยท LQR Dislodger, Stone, Biliary
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Sep 3, 2009 |
| Received | May 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2021 | Aomori Olympus Co., Ltd. B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones. Terminated |
FGE | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones. Terminated |
FGE | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.