STERI-VAC GAS STERILIZER MODEL 5XL
FDA 510(k) clearance K902036 · decided 1990-07-19
Clearance details
- K-number
- K902036
- Device name
- STERI-VAC GAS STERILIZER MODEL 5XL
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1990-05-03
- Decision date
- 1990-07-19
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- FLF
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cottae Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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| ABTOX PLAZLYTE PROCESS MONITOR (K923442) | Abtox, Inc. | 1994-12-22 |
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| STERI-VAC GAS STERILIZER MODEL 8XL (K941748) | 3M Health Care, Ltd. | 1994-12-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Ster recall (Z-1318-2014) | 3M Company - Health Care Business | 2014-04-02 |
| 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerato recall (Z-0022-2013) | 3M Company - Health Care Business | 2012-10-09 |
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 |