SterilContainer S
FDA 510(k) clearance K151242 · decided 2015-10-09
Clearance details
- K-number
- K151242
- Device name
- SterilContainer S
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-05-11
- Decision date
- 2015-10-09
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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| Sterilization Trays (K251756) | Paragon Implant Mfg., LLC | 2025-11-14 |
| Plastic Surgical Kits (K251300) | Dentsply Sirona, Inc. | 2025-07-22 |
| Guided DAS Surgical Kit (K243425) | Talladium España, SL | 2025-07-22 |
| PAL Sterilization Case (K243589) | Microaire Surgical Instruments, LLC | 2025-06-20 |
| Aesculap Aicon® Series Container System (K242762) | Aesculap, Inc. | 2025-05-13 |
| ONE TRAY® Sealed Sterilization Container System (K250029) | Innovative Sterilization Technologies | 2025-05-01 |
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Recalls involving this device
No recalls on record reference this clearance.