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

Esophageal Thermal Regulation And Gastric Suctioning Device

21 CFR 870.5910 / Cardiovascular
FDA source (opens on fda.gov)

PLA is the FDA product code for Esophageal Thermal Regulation And Gastric Suctioning Device, a class II device type, regulated under 21 CFR 870.5910. FDA's definition for this code reads: "The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PLA
Device name
Esophageal Thermal Regulation And Gastric Suctioning Device
FDA definition
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
Regulation
21 CFR 870.5910
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
0

Clearances, product code PLA

By decision year
9 clearances under product code PLA with a decision year between 2015 and 2025, 2018 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PLA by decision year
YearClearances
20151
20161
20172
20183
20241
20251

Applicants with the most clearances

Product code PLA
Applicants holding the most 510(k) clearances under product code PLA
ApplicantClearances
Advanced Cooling Therapy, LLC3
Advanced Cooling Therapy, Inc. D/B/A Attune Medical2
Attune Medical2
Arctx Medical1
Nuvaira, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code