Triton Sponge System
FDA 510(k) clearance K163507 · decided 2017-04-25
Clearance details
- K-number
- K163507
- Device name
- Triton Sponge System
- Applicant
- Gauss Surgical, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2016-12-14
- Decision date
- 2017-04-25
- Days to decision
- 132 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SurgiCount+ System (K252282) | Stryker Instruments | 2026-03-16 |
| SurgiCount+ System (K232250) | Stryker Instruments | 2024-01-11 |
| Triton System (K160338) | Gauss Surgical, Inc., | 2016-08-05 |
| Triton Canister System (K142801) | Gauss Surgical, Inc., | 2015-03-12 |
| PIXEL 3 SYSTEM (DEN130015) | Gauss Surgical, Inc., | 2014-05-09 |
Recalls involving this device
No recalls on record reference this clearance.