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

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

21 CFR 880.2805 / General Hospital
FDA source (opens on fda.gov)

OWP is the FDA product code for Biological Sterilization Process Indicator With Recombinant-Dna Plasmid, a class II device type, regulated under 21 CFR 880.2805. FDA's definition for this code reads: "A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OWP
Device name
Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
FDA definition
A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.
Regulation
21 CFR 880.2805
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
5
Ingested recalls
0

Clearances, product code OWP

By decision year
5 clearances under product code OWP with a decision year between 2013 and 2018, 2017 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OWP by decision year
YearClearances
20131
20173
20181

Applicants with the most clearances

Product code OWP
Applicants holding the most 510(k) clearances under product code OWP
ApplicantClearances
STERIS Corporation5

Companies listing this code with FDA

Companies whose registered establishments list this code