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FDA 510(k)

ENDOBUTTON DIRECT

K-Number: K102982 · 2011-01-05

ApplicantSmith & Nephew Inc., Endoscopy Division
Decision Date2011-01-05
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOBUTTON DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Division. It received FDA 510(k) clearance on 2011-01-05 under 510(k) number K102982. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOBUTTON DIRECT?

ENDOBUTTON DIRECT is a medical device that received FDA 510(k) clearance on 2011-01-05. The listed applicant is Smith & Nephew Inc., Endoscopy Division. The 510(k) number is K102982.

When did ENDOBUTTON DIRECT receive FDA 510(k) clearance?

ENDOBUTTON DIRECT received FDA 510(k) clearance on 2011-01-05, under 510(k) number K102982.

Who is the listed applicant for ENDOBUTTON DIRECT?

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

What is the FDA product code for ENDOBUTTON DIRECT?

The FDA product code for ENDOBUTTON DIRECT is MAI.

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Other records listing Smith & Nephew Inc., Endoscopy Division as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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