FDA 510(k)

AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*

K-Number: K890270 · 1989-03-17

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1989-03-17

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER* 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 1989-03-17 under 510(k) number K890270. 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 ABSORBABLE FASCIA SURGICAL STAPLER*?

AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER* is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K890270.

When did AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER* receive FDA 510(k) clearance?

AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER* received FDA 510(k) clearance on 1989-03-17, under 510(k) number K890270.

Who is the listed applicant for AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*?

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 ABSORBABLE FASCIA SURGICAL STAPLER*?

The FDA product code for AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER* 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.