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

Spatial Imaging For Display Of Endoscope Position

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PGU is the FDA product code for Spatial Imaging For Display Of Endoscope Position, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To detect and display the shape of an inserted endoscope". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PGU
Device name
Spatial Imaging For Display Of Endoscope Position
FDA definition
To detect and display the shape of an inserted endoscope.
Regulation
21 CFR 876.1500
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 PGU

By decision year
1 clearance under product code PGU with a decision year between 2014 and 2014, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PGU by decision year
YearClearances
20141

Applicants with the most clearances

Product code PGU
Applicants holding the most 510(k) clearances under product code PGU
ApplicantClearances
Olympus Medical Systems Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code