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

FDA 510(k)

Thunderbeat Open Fine Jaw Type X Hand Instrument

K-Number: K192103 · 2020-05-11

ApplicantOlympus Medical Systems Corp.
Decision Date2020-05-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thunderbeat Open Fine Jaw Type X Hand Instrument is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-05-11 under approval number K192103. 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 Thunderbeat Open Fine Jaw Type X Hand Instrument?

Thunderbeat Open Fine Jaw Type X Hand Instrument is a medical device that received FDA 510(k) clearance on 2020-05-11. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K192103.

When was Thunderbeat Open Fine Jaw Type X Hand Instrument approved by the FDA?

Thunderbeat Open Fine Jaw Type X Hand Instrument received FDA 510(k) clearance on 2020-05-11, under approval number K192103.

What company makes Thunderbeat Open Fine Jaw Type X Hand Instrument?

Thunderbeat Open Fine Jaw Type X Hand Instrument is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Thunderbeat Open Fine Jaw Type X Hand Instrument?

The FDA product code for Thunderbeat Open Fine Jaw Type X Hand Instrument is GEI.

Other Devices by Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

View all 77 devices →

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑