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FDA 510(k)

BIASURGE Advanced Surgical Solution

K-Number: K223377 · 2023-03-30

ApplicantRochal Technologies, LLC
Decision Date2023-03-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

BIASURGE Advanced Surgical Solution is a medical device manufactured by Rochal Technologies, LLC. It received FDA 510(k) clearance on 2023-03-30 under approval number K223377. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIASURGE Advanced Surgical Solution?

BIASURGE Advanced Surgical Solution is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Rochal Technologies, LLC. The 510(k) number is K223377.

When was BIASURGE Advanced Surgical Solution approved by the FDA?

BIASURGE Advanced Surgical Solution received FDA 510(k) clearance on 2023-03-30, under approval number K223377.

What company makes BIASURGE Advanced Surgical Solution?

BIASURGE Advanced Surgical Solution is manufactured by Rochal Technologies, LLC.

What is the FDA product code for BIASURGE Advanced Surgical Solution?

The FDA product code for BIASURGE Advanced Surgical Solution is FRO. This falls under the Anesthesiology category.

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Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40190248 Revolutionizing Laboratory Practices: Pioneering Trends in Total Laboratory Automation. Annals of laboratory medicine (2025)

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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.

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