Ultrasonic Bipolar Generator USG-410 with accessories
FDA 510(k) K211838 · Olympus Medical Systems Corporation
510(k) numberK211838
Submission
- Device name
- Ultrasonic Bipolar Generator USG-410 with accessories
- Applicant
- Olympus Medical Systems Corporation
Hachioji-Shi, JP - Received
- June 14, 2021
- Decision date
- August 4, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Device class
- Unclassified
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Questions and answers
When was Ultrasonic Bipolar Generator USG-410 with accessories cleared by the FDA?
Ultrasonic Bipolar Generator USG-410 with accessories (K211838) received a 510(k) decision of Substantially Equivalent on August 4, 2021, 51 days after the submission was received.
What is the product code of K211838?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.