FDA 510(k)

AXCESS SOFT TIP WIRE GUIDE

K-Number: K122816 · 2012-10-09

Decision Date2012-10-09

Product CodeOCY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AXCESS SOFT TIP WIRE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2012-10-09 under 510(k) number K122816. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXCESS SOFT TIP WIRE GUIDE?

AXCESS SOFT TIP WIRE GUIDE is a medical device that received FDA 510(k) clearance on 2012-10-09. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K122816.

When did AXCESS SOFT TIP WIRE GUIDE receive FDA 510(k) clearance?

AXCESS SOFT TIP WIRE GUIDE received FDA 510(k) clearance on 2012-10-09, under 510(k) number K122816.

Who is the listed applicant for AXCESS SOFT TIP WIRE GUIDE?

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

What is the FDA product code for AXCESS SOFT TIP WIRE GUIDE?

The FDA product code for AXCESS SOFT TIP WIRE GUIDE is OCY.

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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.