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FDA 510(k)

SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION

K-Number: K911105 · 1991-08-07

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1991-08-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1991-08-07 under 510(k) number K911105. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION?

SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION is a medical device that received FDA 510(k) clearance on 1991-08-07. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K911105.

When did SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION receive FDA 510(k) clearance?

SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION received FDA 510(k) clearance on 1991-08-07, under 510(k) number K911105.

Who is the listed applicant for SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION?

The FDA product code for SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION is GCJ.

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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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