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FDA 510(k)

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

K-Number: K250483 · 2025-09-09

ApplicantStryker Instruments
Decision Date2025-09-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2025-09-09 under approval 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. It is manufactured by Stryker Instruments. The 510(k) number is K250483.

When was PhotonBlade 3; PhotonBlade 3 Smoke Evacuation approved by the FDA?

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation received FDA 510(k) clearance on 2025-09-09, under approval number K250483.

What company makes PhotonBlade 3; PhotonBlade 3 Smoke Evacuation?

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation is manufactured by Stryker Instruments.

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.

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