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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 a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2022-09-16 under approval 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. It is manufactured by Stryker Corporation. The 510(k) number is K221074.

When was OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device approved by the FDA?

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

What company makes OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is manufactured by Stryker Corporation.

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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Related PubMed Literature

PMID: 40037580 "Frank Antagonism to Patterned Organization": Medical Technology, Professional Power, and the Development of US Medical Device Regulation, 1950-1976. Journal of the history of medicine and allied sciences (2025)

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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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