Decision Date2025-09-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K250483. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Stryker Instruments. The 510(k) number is K250483.
When did PhotonBlade 3; PhotonBlade 3 Smoke Evacuation receive FDA 510(k) clearance?
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation received FDA 510(k) clearance on 2025-09-09, under 510(k) number K250483.
Who is the listed applicant for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?
The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?
The FDA product code for PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is GEI.
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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.