AUTO SUTURE DISPOSABLE GIA SURG. STAPLER— 510(k) K801590

Name: FDA 510(k) clearance K801590
Creator: U.S. Food and Drug Administration
Published: 1980-08-04

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K801590 for AUTO SUTURE DISPOSABLE GIA SURG. STAPLER, Substantially Equivalent on 1980-08-04. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 1.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code FHM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1980-07-11
Decision date: 1980-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHM

view all

K801589 — AUTO SUTURE DISP. 30, ETC. & SURG. STAP1980-08-04

More clearances from United States Surgical, A Division of Tyco Healthc

view all

K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER2007-11-21
K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR2007-09-28
K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER2006-11-02
K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2006-10-23
K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE2006-09-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.