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

Two Or More Sterilant Sterilizer

21 CFR 880.6860 / General Hospital
FDA source (opens on fda.gov)

PJJ is the FDA product code for Two Or More Sterilant Sterilizer, a class II device type, regulated under 21 CFR 880.6860. FDA's definition for this code reads: "Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PJJ
Device name
Two Or More Sterilant Sterilizer
FDA definition
Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code PJJ

By decision year
6 clearances under product code PJJ with a decision year between 2014 and 2019, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PJJ by decision year
YearClearances
20141
20162
20182
20191

Applicants with the most clearances

Product code PJJ
Applicants holding the most 510(k) clearances under product code PJJ
ApplicantClearances
Tso3, Inc.4
Ts03, Inc.1
Tso3, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PJJ.