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

Endoscope, Accessories, Image Post-Processing For Color Enhancement

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

PEA is the FDA product code for Endoscope, Accessories, Image Post-Processing For Color Enhancement, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
PEA
Device name
Endoscope, Accessories, Image Post-Processing For Color Enhancement
FDA definition
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
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
9
Ingested recalls
4

Clearances, product code PEA

By decision year
9 clearances under product code PEA with a decision year between 2013 and 2025, 2019 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PEA by decision year
YearClearances
20131
20141
20151
20161
20181
20192
20231
20251

Applicants with the most clearances

Product code PEA
Applicants holding the most 510(k) clearances under product code PEA
ApplicantClearances
PENTAX of America, Inc.7
Boston Scientific Corporation1
FUJIFILM Healthcare Americas Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code