Product code OWP— General Hospital
VERIFY Assert Self-Contained Biological Indicator
- Classification name
- Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
- Device class
- Class 2
- Regulation
- 21 CFR 880.2805
- Advisory panel
- General Hospital
- Total cleared
- 5
- First cleared
- Most recent
FDA classification 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.”
Market context for product code OWP
FDA has cleared devices under product code OWP between 2013 and 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2017
- 2013
Top applicants under product code OWP
Recent clearances under product code OWP
- K181442 — VERIFY Assert Self-Contained Biological Indicator
- K162945 — VERIFY ASSERT STEAM Process Challenge Device
- K162701 — VERIFY Assert Self-Contained Biological Indicator
- K163587 — VERIFY Incubator for Assert Self Contained Biological Indicators
- DEN110006 — VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.