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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 the device name listed in this FDA 510(k) record. The listed applicant is Rochal Technologies, LLC. It received FDA 510(k) clearance on 2023-03-30 under 510(k) 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. The listed applicant is Rochal Technologies, LLC. The 510(k) number is K223377.

When did BIASURGE Advanced Surgical Solution receive FDA 510(k) clearance?

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

Who is the listed applicant for BIASURGE Advanced Surgical Solution?

The FDA 510(k) record lists Rochal Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

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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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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