ELMED Laparoscopic Instruments and Accessories
K-Number: K181173 · 2019-03-22
ApplicantElmed Incorporated
Decision Date2019-03-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ELMED Laparoscopic Instruments and Accessories is a medical device manufactured by Elmed Incorporated. It received FDA 510(k) clearance on 2019-03-22 under approval number K181173. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ELMED Laparoscopic Instruments and Accessories?
ELMED Laparoscopic Instruments and Accessories is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Elmed Incorporated. The 510(k) number is K181173.
When was ELMED Laparoscopic Instruments and Accessories approved by the FDA?
ELMED Laparoscopic Instruments and Accessories received FDA 510(k) clearance on 2019-03-22, under approval number K181173.
What company makes ELMED Laparoscopic Instruments and Accessories?
ELMED Laparoscopic Instruments and Accessories is manufactured by Elmed Incorporated.
What is the FDA product code for ELMED Laparoscopic Instruments and Accessories?
The FDA product code for ELMED Laparoscopic Instruments and Accessories is GCJ.
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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.