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FDA 510(k)

MIRA Surgical System

K-Number: K260817 · 2026-08-20

ApplicantVirtual Incision
Decision Date2026-08-20
Product CodeSAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIRA Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Virtual Incision. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K260817. The device is classified under product code SAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIRA Surgical System?

MIRA Surgical System is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Virtual Incision. The 510(k) number is K260817.

When did MIRA Surgical System receive FDA 510(k) clearance?

MIRA Surgical System received FDA 510(k) clearance on 2026-08-20, under 510(k) number K260817.

Who is the listed applicant for MIRA Surgical System?

The FDA 510(k) record lists Virtual Incision as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIRA Surgical System?

The FDA product code for MIRA Surgical System is SAB.

Related Clinical Trials

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.

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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.

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