Last synced on 14 November 2025 at 11:06 pm

OptaBlate Radiofrequency (RF) Generator System

Page Type
Cleared 510(K)
510(k) Number
K250327
510(k) Type
Special
Applicant
Stryker Instruments
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/15/2025
Days to Decision
69 days
Submission Type
Summary

OptaBlate Radiofrequency (RF) Generator System

Page Type
Cleared 510(K)
510(k) Number
K250327
510(k) Type
Special
Applicant
Stryker Instruments
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/15/2025
Days to Decision
69 days
Submission Type
Summary