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FDA 510(k)

Ultrasonic Bipolar Generator USG-410 with accessories

K-Number: K211838 · 2021-08-04

Decision Date2021-08-04
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Bipolar Generator USG-410 with accessories 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 2021-08-04 under 510(k) number K211838. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Bipolar Generator USG-410 with accessories?

Ultrasonic Bipolar Generator USG-410 with accessories is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K211838.

When did Ultrasonic Bipolar Generator USG-410 with accessories receive FDA 510(k) clearance?

Ultrasonic Bipolar Generator USG-410 with accessories received FDA 510(k) clearance on 2021-08-04, under 510(k) number K211838.

Who is the listed applicant for Ultrasonic Bipolar Generator USG-410 with accessories?

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 with accessories?

The FDA product code for Ultrasonic Bipolar Generator USG-410 with accessories is LFL.

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.

View all 112 devices →

Related Devices (Code: LFL)

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.

Official Source

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