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

Colon Capsule Imaging System

21 CFR 876.1330 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PGD is the FDA product code for Colon Capsule Imaging System, a class II device type, regulated under 21 CFR 876.1330. FDA's definition for this code reads: "visualization of the colon for the detection of polyps". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PGD
Device name
Colon Capsule Imaging System
FDA definition
visualization of the colon for the detection of polyps
Regulation
21 CFR 876.1330
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 PGD

By decision year
2 clearances under product code PGD with a decision year between 2014 and 2016, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PGD by decision year
YearClearances
20141
20161

Applicants with the most clearances

Product code PGD
Applicants holding the most 510(k) clearances under product code PGD
ApplicantClearances
Given Imaging Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code