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FDA 510(k)

GPS Advanced; GPS Advanced Cannula

K-Number: K251648 · 2025-06-24

Decision Date2025-06-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GPS Advanced; GPS Advanced Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Prosidyan, Inc.. It received FDA 510(k) clearance on 2025-06-24 under 510(k) number K251648. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GPS Advanced; GPS Advanced Cannula?

GPS Advanced; GPS Advanced Cannula is a medical device that received FDA 510(k) clearance on 2025-06-24. The listed applicant is Prosidyan, Inc.. The 510(k) number is K251648.

When did GPS Advanced; GPS Advanced Cannula receive FDA 510(k) clearance?

GPS Advanced; GPS Advanced Cannula received FDA 510(k) clearance on 2025-06-24, under 510(k) number K251648.

Who is the listed applicant for GPS Advanced; GPS Advanced Cannula?

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

What is the FDA product code for GPS Advanced; GPS Advanced Cannula?

The FDA product code for GPS Advanced; GPS Advanced Cannula is FMF.

Other records listing Prosidyan, Inc. 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: FMF)

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.

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.