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FDA 510(k)

AUTO SUTURE DISP. 30, ETC. & SURG. STAP

K-Number: K801589 · 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 DISP. 30, ETC. & SURG. STAP 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 K801589. 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 DISP. 30, ETC. & SURG. STAP?

AUTO SUTURE DISP. 30, ETC. & SURG. STAP 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 K801589.

When did AUTO SUTURE DISP. 30, ETC. & SURG. STAP receive FDA 510(k) clearance?

AUTO SUTURE DISP. 30, ETC. & SURG. STAP received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801589.

Who is the listed applicant for AUTO SUTURE DISP. 30, ETC. & SURG. STAP?

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 DISP. 30, ETC. & SURG. STAP?

The FDA product code for AUTO SUTURE DISP. 30, ETC. & SURG. STAP is FHM.

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

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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.

K801590AUTO SUTURE DISPOSABLE GIA SURG. STAPLERUnited 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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