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FDA 510(k)

neoClose PDS

K-Number: K173917 · 2018-11-08

ApplicantNeosurgical, Ltd.
Decision Date2018-11-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

neoClose PDS is a medical device manufactured by Neosurgical, Ltd.. It received FDA 510(k) clearance on 2018-11-08 under approval number K173917. 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 neoClose PDS?

neoClose PDS is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Neosurgical, Ltd.. The 510(k) number is K173917.

When was neoClose PDS approved by the FDA?

neoClose PDS received FDA 510(k) clearance on 2018-11-08, under approval number K173917.

What company makes neoClose PDS?

neoClose PDS is manufactured by Neosurgical, Ltd..

What is the FDA product code for neoClose PDS?

The FDA product code for neoClose PDS 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.

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