Panels › Gastroenterology, Urology › Product code FAS · Class 2
Electrode, Electrosurgical, Active, Urological
Regulation 876.4300
1510(k)s in 12 months (58 all time)
0recalls in 12 months (9 all time)
8recalls that name a 510(k)
Top companies in FAS
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Winter & Ibe GmbH | 6 | 0 |
| Arthrocare Corp. | 5 | 0 |
| Aomori Olympus Co., Ltd. | 0 | 4 |
| Omnitech Systems, Inc. | 4 | 0 |
| C.R. Bard, Inc. | 2 | 1 |
| Greenwald Surgical Co., Inc. | 3 | 0 |
| Gyrus Acmi, Inc. | 2 | 1 |
| Olympus Corporation of the Americas | 0 | 3 |
| American Medical Systems, Inc. | 2 | 0 |
| Applied Urology, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2023 | Olympus Corporation of the Americas ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product p Open, Classified |
FAS | K890328 |
| Aug 17, 2023 | Olympus Corporation of the Americas HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.
64 Models:
1) A22201C
2) A222 Open, Classified |
FAS | K100275 K102781 +2 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
FAS | K955650 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
FAS | K955650 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
FAS | K955650 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
FAS | K955650 |
| Apr 17, 2018 | Gyrus Acmi, Incorporated Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700)
The cord consists of a single conductor stranded wire terminated with plugs that connect to a gen Terminated |
FAS | K890328 |
| Nov 3, 2016 | Olympus Corporation of the Americas HF Cable WA00014A, Endoscopic electrosurgical unit and accessories Terminated |
FAS | K120418 |
| Oct 12, 2016 | C.R. Bard, Inc. C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014. Terminated |
FAS | None listed |
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