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

Basin For Endoscope Reprocessing

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

PHT is the FDA product code for Basin For Endoscope Reprocessing, a class I device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To allow endoscopes to soak in reprocessing solutions". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PHT
Device name
Basin For Endoscope Reprocessing
FDA definition
To allow endoscopes to soak in reprocessing solutions.
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code