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FDA 510(k)

ANSPACH MICROMAX SYSTEM

K-Number: K965080 · 1997-01-10

ApplicantThe Anspach Effort, Inc.
Decision Date1997-01-10
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ANSPACH MICROMAX SYSTEM 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 1997-01-10 under 510(k) number K965080. 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 ANSPACH MICROMAX SYSTEM?

ANSPACH MICROMAX SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K965080.

When did ANSPACH MICROMAX SYSTEM receive FDA 510(k) clearance?

ANSPACH MICROMAX SYSTEM received FDA 510(k) clearance on 1997-01-10, under 510(k) number K965080.

Who is the listed applicant for ANSPACH MICROMAX SYSTEM?

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 MICROMAX SYSTEM?

The FDA product code for ANSPACH MICROMAX SYSTEM is ERL.

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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 ToolsK180063OCM-G1 AttachmentK131053ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMK113476ANSPACH DISSECTION TOOLSK082637CRANIAL PERFORATOR

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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