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FDA 510(k)

AUTO SUTURE DISPOSABLE GIA SURG. STAPLER

K-Number: K801590 · 1980-08-04

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1980-08-04
Product CodeFHM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE DISPOSABLE GIA SURG. 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 1980-08-04 under 510(k) number K801590. The device is classified under product code FHM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE DISPOSABLE GIA SURG. STAPLER?

AUTO SUTURE DISPOSABLE GIA SURG. STAPLER is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K801590.

When did AUTO SUTURE DISPOSABLE GIA SURG. STAPLER receive FDA 510(k) clearance?

AUTO SUTURE DISPOSABLE GIA SURG. STAPLER received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801590.

Who is the listed applicant for AUTO SUTURE DISPOSABLE GIA SURG. 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 DISPOSABLE GIA SURG. STAPLER?

The FDA product code for AUTO SUTURE DISPOSABLE GIA SURG. STAPLER is FHM.

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Other records listing United States Surgical, A Division of Tyco Healthc 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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Related Devices (Code: FHM)

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.

K801589AUTO SUTURE DISP. 30, ETC. & SURG. STAPUnited States Surgical, A Division of Tyco Healthc

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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