FDA 510(k)

ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094

K-Number: K062712 · 2007-01-26

Decision Date2007-01-26

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2007-01-26 under 510(k) number K062712. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094?

ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 is a medical device that received FDA 510(k) clearance on 2007-01-26. The listed applicant is Erbe USA, Inc.. The 510(k) number is K062712.

When did ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 receive FDA 510(k) clearance?

ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 received FDA 510(k) clearance on 2007-01-26, under 510(k) number K062712.

Who is the listed applicant for ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094?

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

What is the FDA product code for ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094?

The FDA product code for ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 is GEI.

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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.