Triton Canister System
FDA 510(k) clearance K142801 · decided 2015-03-12
Clearance details
- K-number
- K142801
- Device name
- Triton Canister System
- Applicant
- Gauss Surgical, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2014-09-29
- Decision date
- 2015-03-12
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- PBZ
- Device class
- 2
- Regulation number
- 880.2750
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Los Altos, CA, US
- Third-party review
- No
- Expedited review
- No
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| SurgiCount+ System (K252282) | Stryker Instruments | 2026-03-16 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Numbe recall (Z-1184-2023) | Stryker Corporation | 2023-02-27 |
| Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Numbe recall (Z-1185-2023) | Stryker Corporation | 2023-02-27 |
| Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blo recall (Z-1186-2023) | Stryker Corporation | 2023-02-27 |