510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K961856Substantially Equivalent

Auto Suture Chemosite Tunneler

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

K961856 is the FDA 510(k) clearance record for AUTO SUTURE CHEMOSITE TUNNELER, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days). 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 K961856.

Clearance record

Decision date
Received
(65 days to decision)
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
510(k) summary
Summary
Third party review
No

Clearances, product code LJS

Trailing 12 months
3 clearances under product code LJS in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJS, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260