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FDA 510(k)

HELIX HYDRO-JET

K-Number: K022613 · 2002-10-25

ApplicantErbe USA, Inc.
Decision Date2002-10-25
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HELIX HYDRO-JET 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 2002-10-25 under 510(k) number K022613. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIX HYDRO-JET?

HELIX HYDRO-JET is a medical device that received FDA 510(k) clearance on 2002-10-25. The listed applicant is Erbe USA, Inc.. The 510(k) number is K022613.

When did HELIX HYDRO-JET receive FDA 510(k) clearance?

HELIX HYDRO-JET received FDA 510(k) clearance on 2002-10-25, under 510(k) number K022613.

Who is the listed applicant for HELIX HYDRO-JET?

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 HELIX HYDRO-JET?

The FDA product code for HELIX HYDRO-JET is FQH.

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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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