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 the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2019-07-19 under 510(k) 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. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K183545.

When did Anspach Helix Dissection Tools receive FDA 510(k) clearance?

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

Who is the listed applicant for Anspach Helix Dissection Tools?

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

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

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

Other records listing The Anspach Effort, Inc. as applicant

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.

K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)K180063OCM-G1 Attachment

Related Devices (Code: HBE)

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.