FDA 510(k)

EndoTool SubQ

K-Number: K180366 · 2018-09-20

Decision Date2018-09-20

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

EndoTool SubQ is the device name listed in this FDA 510(k) record. The listed applicant is Al Pacheco and Associates. It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K180366. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoTool SubQ?

EndoTool SubQ is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Al Pacheco and Associates. The 510(k) number is K180366.

When did EndoTool SubQ receive FDA 510(k) clearance?

EndoTool SubQ received FDA 510(k) clearance on 2018-09-20, under 510(k) number K180366.

Who is the listed applicant for EndoTool SubQ?

The FDA 510(k) record lists Al Pacheco and Associates as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoTool SubQ?

The FDA product code for EndoTool SubQ is NDC.

Related Devices (Code: NDC)

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.

K254102GlucommanderGlytec, LLC K260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic Minimed K253281UpDocUpdoc, Inc.K252104T1D1Comerge AG K241088EndoTool IV (3.1)Monarch Medical Technologies

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.