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FDA 510(k)

VERTICALE GPS Instruments

K-Number: K254148 · 2026-02-19

ApplicantSilony Medical GmbH
Decision Date2026-02-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VERTICALE GPS Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K254148. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTICALE GPS Instruments?

VERTICALE GPS Instruments is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Silony Medical GmbH. The 510(k) number is K254148.

When did VERTICALE GPS Instruments receive FDA 510(k) clearance?

VERTICALE GPS Instruments received FDA 510(k) clearance on 2026-02-19, under 510(k) number K254148.

Who is the listed applicant for VERTICALE GPS Instruments?

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

What is the FDA product code for VERTICALE GPS Instruments?

The FDA product code for VERTICALE GPS Instruments is OLO.

Other records listing Silony Medical GmbH as applicant

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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Related Devices (Code: OLO)

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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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