Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
The Biological Sterilization Process Indicator with Recombinant-DNA Plasmid is a general hospital device intended to accompany products being sterilized through a sterilization procedure in order to monitor the adequacy of sterilization, using a recombinant-DNA plasmid biological indicator. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWP, with regulation number 880.2805 under the General Hospital medical specialty.
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Basic Information
- Product Code
- OWP
- Device Class
- FDA class 2
- Regulation Number
- 880.2805
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K181442 | VERIFY Assert Self-Contained Biological Indicator | Jun 13, 2018 | Substantially Equivalent | STERIS Corporation |
| K162945 | VERIFY ASSERT STEAM Process Challenge Device | Apr 28, 2017 | Substantially Equivalent | STERIS Corporation |
| K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | Mar 24, 2017 | Substantially Equivalent | STERIS Corporation |
| K162701 | VERIFY Assert Self-Contained Biological Indicator | Mar 24, 2017 | Substantially Equivalent | STERIS Corporation |
| DEN110006 | VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR | Jul 12, 2013 | Unknown | STERIS Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.