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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 the device name listed in this FDA 510(k) record. The listed applicant is Neosurgical, Ltd.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) 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. The listed applicant is Neosurgical, Ltd.. The 510(k) number is K173917.

When did neoClose PDS receive FDA 510(k) clearance?

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

Who is the listed applicant for neoClose PDS?

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

What is the FDA product code for neoClose PDS?

The FDA product code for neoClose PDS is GCJ.

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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