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FDA 510(k)

Zimmer Guide Wire Devices

K-Number: K191238 · 2019-07-05

ApplicantZimmer, Inc.
Decision Date2019-07-05
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Guide Wire Devices is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K191238. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Guide Wire Devices?

Zimmer Guide Wire Devices is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Zimmer, Inc.. The 510(k) number is K191238.

When did Zimmer Guide Wire Devices receive FDA 510(k) clearance?

Zimmer Guide Wire Devices received FDA 510(k) clearance on 2019-07-05, under 510(k) number K191238.

Who is the listed applicant for Zimmer Guide Wire Devices?

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

What is the FDA product code for Zimmer Guide Wire Devices?

The FDA product code for Zimmer Guide Wire Devices is HSB.

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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.

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