FDA 510(k)

OCM-G1 Attachment

K-Number: K180063 · 2018-03-27

Decision Date2018-03-27

Product CodeERL

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

OCM-G1 Attachment is a medical device manufactured by The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2018-03-27 under approval number K180063. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCM-G1 Attachment?

OCM-G1 Attachment is a medical device that received FDA 510(k) clearance on 2018-03-27. It is manufactured by The Anspach Effort, Inc.. The 510(k) number is K180063.

When was OCM-G1 Attachment approved by the FDA?

OCM-G1 Attachment received FDA 510(k) clearance on 2018-03-27, under approval number K180063.

What company makes OCM-G1 Attachment?

OCM-G1 Attachment is manufactured by The Anspach Effort, Inc..

What is the FDA product code for OCM-G1 Attachment?

The FDA product code for OCM-G1 Attachment is ERL.

Other Devices by The Anspach Effort, Inc.

K183545Anspach Helix Dissection Tools K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)

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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.