3M STERI-VAC STERILIZER/AERATOR
FDA 510(k) clearance K142034 · decided 2015-01-08
Clearance details
- K-number
- K142034
- Device name
- 3M STERI-VAC STERILIZER/AERATOR
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 2014-07-28
- Decision date
- 2015-01-08
- Days to decision
- 164 days
- Clearance type
- Abbreviated
- Product code
- FLF
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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| TSO3 OZONE STERILIZER, MODEL 125L (K090636) | Tso3, Inc. | 2009-12-02 |
| TSO3 OZONE STERILIZER, MODEL 125L (K051595) | Tso3, Inc. | 2006-07-26 |
| TSO3 OZONE STERILIZER, MODEL 125L (K020875) | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003-08-26 |
| H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (K014013) | H & W Technology, LLC | 2003-06-25 |
| STERRAD 50 & STERRAD 100S STERILIZERS (K023290) | Advanced Sterilization Products | 2003-04-03 |
| ABTOX PLAZLYTE PROCESS MONITOR (K923442) | Abtox, Inc. | 1994-12-22 |
| PLAZLYTE(TM) (K905119) | Abtox, Inc. | 1994-12-22 |
| STERI-VAC GAS STERILIZER MODEL 8XL (K941748) | 3M Health Care, Ltd. | 1994-12-02 |
| THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER (K931872) | American Sterilizer Co. | 1994-02-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |