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

Endoscopic Light-Projecting Measuring Device

21 CFR 876.1530 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QTH is the FDA product code for Endoscopic Light-Projecting Measuring Device, a class II device type, regulated under 21 CFR 876.1530. FDA's definition for this code reads: "An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QTH
Device name
Endoscopic Light-Projecting Measuring Device
FDA definition
An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.
Regulation
21 CFR 876.1530
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
1
Ingested recalls
0

Clearances, product code QTH

By decision year
1 clearance under product code QTH with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTH by decision year
YearClearances
20221

Applicants with the most clearances

Product code QTH
Applicants holding the most 510(k) clearances under product code QTH
ApplicantClearances
Rqmis Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code