FDA 510(k)

OXINIUM DH Fermoral Heads

K-Number: K161233 · 2016-12-14

Decision Date2016-12-14

Product CodeMBL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OXINIUM DH Fermoral Heads is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K161233. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXINIUM DH Fermoral Heads?

OXINIUM DH Fermoral Heads is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K161233.

When did OXINIUM DH Fermoral Heads receive FDA 510(k) clearance?

OXINIUM DH Fermoral Heads received FDA 510(k) clearance on 2016-12-14, under 510(k) number K161233.

Who is the listed applicant for OXINIUM DH Fermoral Heads?

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

What is the FDA product code for OXINIUM DH Fermoral Heads?

The FDA product code for OXINIUM DH Fermoral Heads is MBL.

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Other records listing Smith & Nephew, Inc. as applicant

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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.