510(k) K211838 ยท LFL Instrument, Ultrasonic Surgical
Ultrasonic Bipolar Generator USG-410 with accessories
| Applicant | Olympus Medical Systems Corporation, Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Aug 4, 2021 |
| Received | Jun 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S
Model Number: TB-0535FCS
Catalog Number/Product Code: R5000 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: Thunderbeat Front-Actuated Grip Type S
Model Number: TB-0545FCS
Catalog Number/Product Code: R5000688
Software Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S
Model Number: TB-0520FCS
Catalog Number/Product Code: N54240 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S
Model Number: TB-0535FCS
Catalog Number/Product Code: N54237 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S
Model Number: TB-0535FCS
Catalog Number/Product Code: N54236 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S
Model Number: TB-0545FCS
Catalog Number/Product Code: N54233 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S
Model Number: TB-0545FCS
Catalog Number/Product Code: N542343 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S
Model Number: TB-0545FCS
Catalog Number/Product Code: N542351 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S
Model Number: TB-0520FCS
Catalog Number/Product Code: N5423 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S
Model Number: TB-0520FCS
Catalog Number/Product Code: N5424 Open, Classified |
LFL | None listed |
| Jan 21, 2025 | Olympus Corporation of the Americas Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S
Model Number: TB-0535FCS
Catalog Number/Product Code: N5423 Open, Classified |
LFL | None listed |
| Oct 12, 2023 | Olympus Corporation of the Americas THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S.
Model: TB-0535FCS
Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, th Open, Classified |
LFL | None listed |
| Oct 12, 2023 | Olympus Corporation of the Americas THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S
Model: TB-0545FCS
Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, tho Open, Classified |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.