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FDA 510(k)

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device

K-Number: K221074 · 2022-09-16

ApplicantStryker Corporation
Decision Date2022-09-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K221074. 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 RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Stryker Corporation. The 510(k) number is K221074.

When did OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device receive FDA 510(k) clearance?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221074.

Who is the listed applicant for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

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

What is the FDA product code for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

The FDA product code for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is GEI.

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Official Source

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