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FDA 510(k)

AUTO SUTURE ENDOSCOPIC FASCIA STAPLER

K-Number: K912097 · 1991-09-19

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1991-09-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE ENDOSCOPIC FASCIA 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 1991-09-19 under 510(k) number K912097. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE ENDOSCOPIC FASCIA STAPLER?

AUTO SUTURE ENDOSCOPIC FASCIA STAPLER is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K912097.

When did AUTO SUTURE ENDOSCOPIC FASCIA STAPLER receive FDA 510(k) clearance?

AUTO SUTURE ENDOSCOPIC FASCIA STAPLER received FDA 510(k) clearance on 1991-09-19, under 510(k) number K912097.

Who is the listed applicant for AUTO SUTURE ENDOSCOPIC FASCIA 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 ENDOSCOPIC FASCIA STAPLER?

The FDA product code for AUTO SUTURE ENDOSCOPIC FASCIA STAPLER is GCJ.

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Other records listing United States Surgical, A Division of Tyco Healthc as applicant

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Related Devices (Code: GCJ)

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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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