Atlas FDA

QJN

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Laparoscopic Accessories, Esophageal Sizing
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5360
Medical specialty
Gastroenterology, Urology
FDA definition
To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.
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RecordFirmDateBuilder
ETHICON LINX® Esophagus Sizing Tool (K230089)Torax Medical, Inc.2023-02-09+ Add
ETHICON Linx Esophagus Sizing Tool (K201035)Torax Medical, Inc.2020-07-09+ Add

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