STERRAD 100NX STERILIZER
FDA 510(k) clearance K071385 · decided 2007-11-29
Clearance details
- K-number
- K071385
- Device name
- STERRAD 100NX STERILIZER
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2007-05-18
- Decision date
- 2007-11-29
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- MLR
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature recall (Z-0402-2014) | Advanced Sterilization Products | 2013-11-26 |
| STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purp recall (Z-0044-2014) | Advanced Sterilization Products | 2013-10-22 |
| STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low tem recall (Z-2174-2013) | Advanced Sterilization Products | 2013-09-10 |
| STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilizati recall (Z-1026-2013) | Advanced Sterilization Products | 2013-03-30 |
| STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive recall (Z-1632-2008) | Advanced Sterilization Products | 2008-08-08 |