OWP — Biological Sterilization Process Indicator With Recombinant-Dna Plasmid Class II
FDA product code OWP covers "Biological Sterilization Process Indicator With Recombinant-Dna Plasmid", a Class II medical device regulated under 21 CFR 880.2805. Submissions are reviewed by the General Hospital panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OWP
- Device Class
- Class II
- Regulation Number
- 880.2805
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181442 | steris corporation | VERIFY Assert Self-Contained Biological Indicator | June 13, 2018 |
| K162945 | steris corporation | VERIFY ASSERT STEAM Process Challenge Device | April 28, 2017 |
| K162701 | steris corporation | VERIFY Assert Self-Contained Biological Indicator | March 24, 2017 |
| K163587 | steris corporation | VERIFY Incubator for Assert Self Contained Biological Indicators | March 24, 2017 |
| DEN110006 | steris corporation | VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR | July 12, 2013 |