FDA 510(k)

AUTO SUTURE SITE MARKER CLIP

K-Number: K983400 · 1999-02-10

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1999-02-10

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE SITE MARKER CLIP is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1999-02-10 under 510(k) number K983400. 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 AUTO SUTURE SITE MARKER CLIP?

AUTO SUTURE SITE MARKER CLIP is a medical device that received FDA 510(k) clearance on 1999-02-10. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K983400.

When did AUTO SUTURE SITE MARKER CLIP receive FDA 510(k) clearance?

AUTO SUTURE SITE MARKER CLIP received FDA 510(k) clearance on 1999-02-10, under 510(k) number K983400.

Who is the listed applicant for AUTO SUTURE SITE MARKER CLIP?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO SUTURE SITE MARKER CLIP?

The FDA product code for AUTO SUTURE SITE MARKER CLIP is GDW.

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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.