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FDA 510(k)

OCM-G1 Attachment

K-Number: K180063 · 2018-03-27

ApplicantThe Anspach Effort, Inc.
Decision Date2018-03-27
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OCM-G1 Attachment 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 2018-03-27 under 510(k) 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. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K180063.

When did OCM-G1 Attachment receive FDA 510(k) clearance?

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

Who is the listed applicant for OCM-G1 Attachment?

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 OCM-G1 Attachment?

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

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)K183545Anspach Helix Dissection Tools

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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