FDA Product Code
FDA Product Code PBZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2750
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252282 | SurgiCount+ System | Stryker Instruments | 2026-03-16 | Traditional | PDF ↗ |
| K232250 | SurgiCount+ System | Stryker Instruments | 2024-01-11 | Traditional | PDF ↗ |
| K163507 | Triton Sponge System | Gauss Surgical, Inc., | 2017-04-25 | Traditional | PDF ↗ |
| K160338 | Triton System | Gauss Surgical, Inc., | 2016-08-05 | Traditional | PDF ↗ |
| K142801 | Triton Canister System | Gauss Surgical, Inc., | 2015-03-12 | Traditional | PDF ↗ |
| DEN130015 | PIXEL 3 SYSTEM | Gauss Surgical, Inc., | 2014-05-09 | Direct | — |
Product code PBZ · Class II · General Hospital. Data: openFDA.