Sonicision Reusable Sterilization Tray
FDA 510(k) clearance K180915 · decided 2018-07-17
Clearance details
- K-number
- K180915
- Device name
- Sonicision Reusable Sterilization Tray
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2018-04-09
- Decision date
- 2018-07-17
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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| Stainless Steel Surgical Kits (K251614) | Dentsply Sirona, Inc. | 2026-02-06 |
| 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 |
| Synthes Graphic Case & Tray System (K241927) | Synthes GmbH | 2025-03-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006) | Covidien | 1997-06-24 |
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005) | Covidien | 1995-12-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004) | Covidien | 1995-06-14 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003) | Covidien | 1994-06-17 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002) | Covidien | 1994-03-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001) | Covidien | 1993-09-10 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034) | Covidien | 1991-12-13 |