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

Laparoscopic Accessories, Esophageal Sizing

21 CFR 876.5360 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QJN is the FDA product code for Laparoscopic Accessories, Esophageal Sizing, a class II device type, regulated under 21 CFR 876.5360. FDA's definition for this code reads: "To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QJN
Device name
Laparoscopic Accessories, Esophageal Sizing
FDA definition
To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.
Regulation
21 CFR 876.5360
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QJN

By decision year
2 clearances under product code QJN with a decision year between 2020 and 2023, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QJN by decision year
YearClearances
20201
20231

Applicants with the most clearances

Product code QJN
Applicants holding the most 510(k) clearances under product code QJN
ApplicantClearances
Torax Medical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code