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FDA 510(k)

Spiro-VISTA

K-Number: K253437 · 2026-06-12

ApplicantSpiro Robotics
Decision Date2026-06-12
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Spiro-VISTA is the device name listed in this FDA 510(k) record. The listed applicant is Spiro Robotics. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253437. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spiro-VISTA?

Spiro-VISTA is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Spiro Robotics. The 510(k) number is K253437.

When did Spiro-VISTA receive FDA 510(k) clearance?

Spiro-VISTA received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253437.

Who is the listed applicant for Spiro-VISTA?

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

What is the FDA product code for Spiro-VISTA?

The FDA product code for Spiro-VISTA is BTR.

Related Devices (Code: BTR)

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

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