510(k) K162945
- Device
- VERIFY ASSERT STEAM Process Challenge Device
- Applicant
- STERIS Corporation
- 510(k) number
- K162945
- Product code
- OWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-28
- Date received
- 2016-10-21
- Regulation
- 880.2805
- Classification name
- Biological Sterilization Process Indicator With Recombinant-dna Plasmid
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ganga Kolli
- Address
- 5976 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers#
- 3000251274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OWP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181442 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2018-06-13 |
| K162701 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2017-03-24 |
| K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | STERIS Corporation | 2017-03-24 |
| DEN110006 | VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR | STERIS Corporation | 2013-07-12 |
Legacy Summary#
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FDA Review#
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