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FDA 510(k)

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

K-Number: K213831 · 2022-01-04

ApplicantGyrus Acmi, Inc.
Decision Date2022-01-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2022-01-04 under approval number K213831. 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 Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle is a medical device that received FDA 510(k) clearance on 2022-01-04. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K213831.

When was Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle approved by the FDA?

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle received FDA 510(k) clearance on 2022-01-04, under approval number K213831.

What company makes Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle is manufactured by Gyrus Acmi, Inc..

What is the FDA product code for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

The FDA product code for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle is GEI.

Related Clinical Trials

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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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