510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771589Substantially Equivalent

Auto Suture

U. S. Surgical Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771589 is the FDA 510(k) clearance record for AUTO SUTURE, a class I device, cleared for U. S. Surgical Corp. on under FDA product code GDJ (Clamp, Surgical, General & Plastic Surgery). FDA records list 2 510(k) clearances for U. S. Surgical Corp., from to . As of , FDA records show no recalls naming K771589.

Clearance record

Decision date
Received
(116 days to decision)
Product code
GDJ Clamp, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
U. S. Surgical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GDJ

Trailing 12 months

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

FDA records show no clearances under product code GDJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDJ, 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