FDA 510(k)

Anspach Helix Dissection Tools

K-Number: K183545 · 2019-07-19

Decision Date2019-07-19

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Anspach Helix Dissection Tools is a medical device manufactured by The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2019-07-19 under approval number K183545. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anspach Helix Dissection Tools?

Anspach Helix Dissection Tools is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by The Anspach Effort, Inc.. The 510(k) number is K183545.

When was Anspach Helix Dissection Tools approved by the FDA?

Anspach Helix Dissection Tools received FDA 510(k) clearance on 2019-07-19, under approval number K183545.

What company makes Anspach Helix Dissection Tools?

Anspach Helix Dissection Tools is manufactured by The Anspach Effort, Inc..

What is the FDA product code for Anspach Helix Dissection Tools?

The FDA product code for Anspach Helix Dissection Tools is HBE.

Other Devices by The Anspach Effort, Inc.

K180063OCM-G1 Attachment 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.