Atlas FDA

Ultrasonic Bipolar Generator USG-410 with accessories

FDA 510(k) clearance K211838 · decided 2021-08-04

Clearance details

K-number
K211838
Device name
Ultrasonic Bipolar Generator USG-410 with accessories
Applicant
Olympus Medical Systems Corporation
Decision
Substantially Equivalent
Date received
2021-06-14
Decision date
2021-08-04
Days to decision
51 days
Clearance type
Traditional
Product code
LFL
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Hachioji-Shi, JP
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-0993-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-0994-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-0995-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-0996-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-0997-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-0998-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-0999-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-1000-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-1001-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-1002-2025)Olympus Corporation of the Americas2025-01-21
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: T recall (Z-1003-2025)Olympus Corporation of the Americas2025-01-21
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, recall (Z-0108-2024)Olympus Corporation of the Americas2023-10-12
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, l recall (Z-0109-2024)Olympus Corporation of the Americas2023-10-12