Gauss Surgical, Inc.,: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Gauss Surgical, Inc.,” (first 2012, latest 2017), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 132 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 57 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 164 |
| 2016 | 1 | 179 |
| 2017 | 1 | 132 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gauss Surgical, Inc., took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 167 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PBZ | Image Processing Device For Estimation Of External Blood Loss | 4 | 3 |
| LWH | Counter, Sponge, Surgical | 2 | 2 |
Review panels
Most recent Gauss Surgical, Inc., 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163507 | Triton Sponge System | PBZ | 2017-04-25 | 132 |
| K160338 | Triton System | PBZ | 2016-08-05 | 179 |
| K142801 | Triton Canister System | PBZ | 2015-03-12 | 164 |
| K121274 | PIXEL APP | LWH | 2012-06-27 | 61 |
| K120473 | PIXEL APP | LWH | 2012-04-09 | 53 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130015 | De Novo | Image Processing Device For Estimation Of External Blood Loss | 2014-05-09 |
Recalls
openFDA lists no recalls under a recalling firm named Gauss Surgical, Inc.,.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gauss Surgical, Inc.,?
FDA lists 5 510(k) clearances under the applicant name “Gauss Surgical, Inc.,” (first 2012, latest 2017), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gauss Surgical, Inc.,?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gauss Surgical, Inc., is 132 days.
Which FDA product codes appear under Gauss Surgical, Inc.,?
The most frequent FDA product codes under this applicant name are PBZ (Image Processing Device For Estimation Of External Blood Loss, 4); LWH (Counter, Sponge, Surgical, 2).
Next steps
- See all 5 Gauss Surgical, Inc., clearances with predicates and recalls
- Run predicate analysis for product code PBZ, Gauss Surgical, Inc.,'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.