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FDA 510(k)

ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM

K-Number: K111843 · 2011-11-14

ApplicantSmith & Nephew Inc., Endoscopy Div.
Decision Date2011-11-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2011-11-14 under 510(k) number K111843. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM?

ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-14. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K111843.

When did ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM receive FDA 510(k) clearance?

ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM received FDA 510(k) clearance on 2011-11-14, under 510(k) number K111843.

Who is the listed applicant for ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM?

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

What is the FDA product code for ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM?

The FDA product code for ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM is OLO.

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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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