STERRAD 100S STERILIZER
FDA 510(k) clearance K991999 · decided 2000-06-15
Clearance details
- K-number
- K991999
- Device name
- STERRAD 100S STERILIZER
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 1999-06-14
- Decision date
- 2000-06-15
- Days to decision
- 367 days
- Clearance type
- Traditional
- Product code
- MLR
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations syst recall (Z-2337-2012) | Advanced Sterilization Products | 2012-09-07 |
| STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardwar recall (Z-0340-2009) | Advanced Sterilization Products | 2008-11-21 |
| STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and moisture recall (Z-1628-2008) | Advanced Sterilization Products | 2008-08-08 |
| STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA recall (Z-0845-2008) | Advanced Sterilization Products | 2008-02-08 |
| STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for U recall (Z-0844-2008) | Advanced Sterilization Products | 2008-02-07 |
| Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STE recall (Z-0197-06) | Advanced Sterilization Products | 2005-11-24 |