510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801589Substantially Equivalent

Auto Suture Disp. 30, Etc. & Surg. Stap

United States Surgical, A Division of Tyco Healthc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801589 is the FDA 510(k) clearance record for AUTO SUTURE DISP. 30, ETC. & SURG. STAP, a class I device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code FHM (Apparatus, Suturing, Stomach And Intestinal). FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K801589.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FHM Apparatus, Suturing, Stomach And Intestinal
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
United States Surgical, A Division of Tyco Healthc 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FHM

Trailing 12 months

FDA records hold no clearances under product code FHM in the trailing twelve months.

FDA records show no clearances under product code FHM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FHM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260