STERI-VAC GAS STERILIZER MODEL 8XL
FDA 510(k) clearance K941748 · decided 1994-12-02
Clearance details
- K-number
- K941748
- Device name
- STERI-VAC GAS STERILIZER MODEL 8XL
- Applicant
- 3M Health Care, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-08
- Decision date
- 1994-12-02
- Days to decision
- 238 days
- Clearance type
- Traditional
- 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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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 |