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FDA 510(k)

PROWICK

K-Number: K083007 · 2009-04-08

ApplicantArthrex, Inc.
Decision Date2009-04-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PROWICK is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2009-04-08 under 510(k) number K083007. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROWICK?

PROWICK is a medical device that received FDA 510(k) clearance on 2009-04-08. The listed applicant is Arthrex, Inc.. The 510(k) number is K083007.

When did PROWICK receive FDA 510(k) clearance?

PROWICK received FDA 510(k) clearance on 2009-04-08, under 510(k) number K083007.

Who is the listed applicant for PROWICK?

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

What is the FDA product code for PROWICK?

The FDA product code for PROWICK is FRO. This falls under the Anesthesiology category.

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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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