Indicator, Sterilization
FDA product code LRT · Class II (moderate risk) · 21 CFR 880.2800 · General Hospital
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K002937 | TST Control Integrator for Steam SterilizersLRT · Traditional | Albert Browne , Ltd. | 11/05/2001SE |
| K965154 | TST Control Integrator for Steam AutoclaveLRT · Traditional | Albert Browne , Ltd. | 09/19/1997SE |
| K951113 | Cross-ChecksLRT · Traditional | Steritec Products Mfg Co, Inc. | 08/19/1996SE |
| K951703 | Tamper Evident Arrows with and Without Sterilization IndicatorsLRT · Traditional | Products For Medicine | 06/28/1995SE |
| K871672 | Sterilization Indicator for Flash SterilizationLRT · Traditional | Propper Mfg. Co., Inc. | 06/01/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2325-2012 Class III | 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes…On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was… | Steris Corporation | 08/02/2012Terminated |