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

Polymer, Ent Synthetic, Porous Polyethylene

21 CFR 874.3620 / Ear, Nose, Throat
FDA source (opens on fda.gov)

JOF is the FDA product code for Polymer, Ent Synthetic, Porous Polyethylene, a class II device type, regulated under 21 CFR 874.3620. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JOF
Device name
Polymer, Ent Synthetic, Porous Polyethylene
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code JOF

By decision year
6 clearances under product code JOF with a decision year between 1977 and 2020, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JOF by decision year
YearClearances
19772
20001
20091
20171
20201

Applicants with the most clearances

Product code JOF
Applicants holding the most 510(k) clearances under product code JOF
ApplicantClearances
Anatomics Pty, Ltd.2
Xomed, Inc.2
Pillar Surgical, Inc.1
Porex Surgical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code