PK Morcellator
K-Number: K161038 · 2016-10-07
ApplicantGyrus Acmi, Inc.
Decision Date2016-10-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PK Morcellator is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2016-10-07 under approval number K161038. 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 PK Morcellator?
PK Morcellator is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K161038.
When was PK Morcellator approved by the FDA?
PK Morcellator received FDA 510(k) clearance on 2016-10-07, under approval number K161038.
What company makes PK Morcellator?
PK Morcellator is manufactured by Gyrus Acmi, Inc..
What is the FDA product code for PK Morcellator?
The FDA product code for PK Morcellator 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.