Decision Date2025-04-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
OptaBlate Radiofrequency (RF) Generator System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2025-04-15 under 510(k) number K250327. 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 OptaBlate Radiofrequency (RF) Generator System?
OptaBlate Radiofrequency (RF) Generator System is a medical device that received FDA 510(k) clearance on 2025-04-15. The listed applicant is Stryker Instruments. The 510(k) number is K250327.
When did OptaBlate Radiofrequency (RF) Generator System receive FDA 510(k) clearance?
OptaBlate Radiofrequency (RF) Generator System received FDA 510(k) clearance on 2025-04-15, under 510(k) number K250327.
Who is the listed applicant for OptaBlate Radiofrequency (RF) Generator System?
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 OptaBlate Radiofrequency (RF) Generator System?
The FDA product code for OptaBlate Radiofrequency (RF) Generator System 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.