Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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)

K-Number: K252150 · 2025-10-07

ApplicantOlympus Medical Systems Corporation
Decision Date2025-10-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-10-07 under 510(k) number K252150. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K252150.

When did 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) receive FDA 510(k) clearance?

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) received FDA 510(k) clearance on 2025-10-07, under 510(k) number K252150.

Who is the listed applicant for 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)?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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)?

The FDA product code for 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) is GEI.

Other records listing Olympus Medical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 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)K261260HD Camera Head OLYMPUS CH-S200-08-LBK260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

View all 112 devices →

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 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)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑