Atlas FDA

Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)

FDA 510(k) clearance K252150 · decided 2025-10-07

Clearance details

K-number
K252150
Device name
Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
Applicant
Olympus Medical Systems Corporation
Decision
Substantially Equivalent
Date received
2025-07-09
Decision date
2025-10-07
Days to decision
90 days
Clearance type
Traditional
Product code
GEI
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Hachioji-Shi, JP
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Olympus Medical Systems Corporation

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
AlphaTriPart - Monopolar MIC Instruments (K261179)Gimmi GmbH2026-07-22
Volnewmer™ (K253504)Classys, Inc.2026-07-13
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) (K254056)Olympus Medical Systems Corp.2026-07-01
LUTRONIC GENIUS (K253484)Cynosure Lutronic Technology Corporation2026-06-29
Irrigation Tubing Bipolar Cord Set (K251492)New Deantronics Taiwan , Ltd.2026-06-29
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (K260636)Stryker Sustainability Solutions2026-06-18
CoolSeal Generator® (CSL-200-90) (K253634)Hologic, Inc.2026-06-17
NEUROMARK System (NMK00301) (K261833)Neurent Medical , Ltd.2026-06-16
LAP-iX2N (K253165)Sejong Medical Co., Ltd.2026-06-09
OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (K253656)Medtronic Sofamor Danek USA, Inc.2026-06-05
MILAN System (K253803)Lumenis Be, Ltd.2026-06-02
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) (K253918)F Care Systems USA, LLC2026-06-02

Recalls involving this device

RecordFirmDate
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. recall (Z-1851-2026)Olympus Corporation of the Americas2026-04-17
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. recall (Z-1852-2026)Olympus Corporation of the Americas2026-04-17
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. recall (Z-1853-2026)Olympus Corporation of the Americas2026-04-17
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. recall (Z-1854-2026)Olympus Corporation of the Americas2026-04-17