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

Polyethylene Glycol (Carbowax)

21 CFR 864.4010 / Pathology
FDA source (opens on fda.gov)

IER is the FDA product code for Polyethylene Glycol (Carbowax), a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
IER
Device name
Polyethylene Glycol (Carbowax)
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code IER

By decision year
1 clearance under product code IER with a decision year between 1985 and 1985, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IER by decision year
YearClearances
19851

Applicants with the most clearances

Product code IER
Applicants holding the most 510(k) clearances under product code IER
ApplicantClearances
Surgipath Medical Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code