FDA 510(k)

URS-HYDRO-DILATOR MODEL NUMBER 2164.00

K-Number: K912331 · 1991-10-30

ApplicantRichard Wolf Medical Instruments Corp.

Decision Date1991-10-30

Product CodeEZN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

URS-HYDRO-DILATOR MODEL NUMBER 2164.00 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K912331. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URS-HYDRO-DILATOR MODEL NUMBER 2164.00?

URS-HYDRO-DILATOR MODEL NUMBER 2164.00 is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K912331.

When did URS-HYDRO-DILATOR MODEL NUMBER 2164.00 receive FDA 510(k) clearance?

URS-HYDRO-DILATOR MODEL NUMBER 2164.00 received FDA 510(k) clearance on 1991-10-30, under 510(k) number K912331.

Who is the listed applicant for URS-HYDRO-DILATOR MODEL NUMBER 2164.00?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URS-HYDRO-DILATOR MODEL NUMBER 2164.00?

The FDA product code for URS-HYDRO-DILATOR MODEL NUMBER 2164.00 is EZN.

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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.