FDA 510(k)

AUTOSUTURE EEA ORVIL

K-Number: K093402 · 2009-11-12

ApplicantSurgical Devices, A Global Business Unit Tyco

Decision Date2009-11-12

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AUTOSUTURE EEA ORVIL is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Devices, A Global Business Unit Tyco. It received FDA 510(k) clearance on 2009-11-12 under 510(k) number K093402. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOSUTURE EEA ORVIL?

AUTOSUTURE EEA ORVIL is a medical device that received FDA 510(k) clearance on 2009-11-12. The listed applicant is Surgical Devices, A Global Business Unit Tyco. The 510(k) number is K093402.

When did AUTOSUTURE EEA ORVIL receive FDA 510(k) clearance?

AUTOSUTURE EEA ORVIL received FDA 510(k) clearance on 2009-11-12, under 510(k) number K093402.

Who is the listed applicant for AUTOSUTURE EEA ORVIL?

The FDA 510(k) record lists Surgical Devices, A Global Business Unit Tyco as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOSUTURE EEA ORVIL?

The FDA product code for AUTOSUTURE EEA ORVIL is GDW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.