FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERRAAD 100NX EXPRESS CYCLE TEST PACK
K Number: K092755
·
Decision Feb 25, 2011
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
54
Review Days
534
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Basic Information
- Device Name
- STERRAAD 100NX EXPRESS CYCLE TEST PACK
- K Number
- K092755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Sterilization Products
- Date Received
- September 9, 2009
- Decision Date
- February 25, 2011
- Product Code
- FRC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by Advanced Sterilization Products
| K Number | Device Name | ||
|---|---|---|---|
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077) | Jul 5, 2024 | Substantially Equivalent |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator | Jul 31, 2017 | Substantially Equivalent |
| K162007 | STERRAD NX Sterilizer | Feb 16, 2017 | Substantially Equivalent |
| K160818 | STERRAD® NX Sterilizer with ALLClear Technology | Sep 27, 2016 | Substantially Equivalent |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | Sep 26, 2016 | Substantially Equivalent |
| K151725 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Jan 13, 2016 | Substantially Equivalent |
| K151971 | STERRAD CYCLESURE 24 Biological Indicator | Oct 29, 2015 | Substantially Equivalent |
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Apr 3, 2015 | Substantially Equivalent |
| K140977 | EVOTECH ECR | Dec 22, 2014 | Substantially Equivalent |
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | Dec 19, 2014 | Substantially Equivalent |