Instrument Case
FDA 510(k) clearance K231604 · decided 2023-08-24
Clearance details
- K-number
- K231604
- Device name
- Instrument Case
- Applicant
- Cochlear Americas
- Decision
- Substantially Equivalent
- Date received
- 2023-06-01
- Decision date
- 2023-08-24
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lone Tree, CO, US
- Third-party review
- No
- Expedited review
- No
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| PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (K253791) | DePuy Mitek, Inc. | 2026-02-26 |
| 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 |
|---|---|---|
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S240) | Cochlear Americas | 2025-12-19 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S058) | Cochlear Americas | 2025-10-16 |
| Nucleus® 24 Cochlear Implant System (P970051/S236) | Cochlear Americas | 2025-10-16 |
| Nucleus® 24 Cochlear Implant System (P970051/S238) | Cochlear Americas | 2025-09-26 |
| Cochlear Nucleus® System (P970051/S237) | Cochlear Americas | 2025-09-02 |
| Nucleus® 24 Cochlear Implant System (P970051/S235) | Cochlear Americas | 2025-08-06 |
| Nucleus® 24 Cochlear Implant System (P970051/S234) | Cochlear Americas | 2025-07-24 |
| Nucleus® 22 Cochlear Implant System (P890027/S064) | Cochlear Americas | 2025-07-03 |