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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 the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2022-01-04 under 510(k) 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. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K213831.

When did Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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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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