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FDA 510(k)

MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM

K-Number: K011612 · 2001-06-22

ApplicantHydrocision, Inc.
Decision Date2001-06-22
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hydrocision, Inc.. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K011612. 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 MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM?

MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is Hydrocision, Inc.. The 510(k) number is K011612.

When did MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM received FDA 510(k) clearance on 2001-06-22, under 510(k) number K011612.

Who is the listed applicant for MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM?

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

What is the FDA product code for MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM?

The FDA product code for MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM is FQH.

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Other records listing Hydrocision, Inc. as applicant

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Related Devices (Code: 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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