510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K201035Substantially Equivalent

ETHICON Linx Esophagus Sizing Tool

Torax Medical, Inc., Shoreview MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201035 is the FDA 510(k) clearance record for ETHICON Linx Esophagus Sizing Tool, a class II device, cleared for Torax Medical, Inc. on under FDA product code QJN (Laparoscopic Accessories, Esophageal Sizing). FDA's definition for product code QJN reads: "To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ". FDA records list 2 510(k) clearances for Torax Medical, Inc., from to . As of , FDA records show no recalls naming K201035.

Clearance record

Decision date
Received
(80 days to decision)
Product code
QJN Laparoscopic Accessories, Esophageal Sizing
Regulation
21 CFR 876.5360
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Torax Medical, Inc. 4188 Lexington Ave., N, Shoreview MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJN

Trailing 12 months

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

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