G Surgical, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “G Surgical, LLC” (first 2015, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 31 days. Since 2017 the median was 29 days, against 84 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 1 | 220 |
| 2016 | 1 | 84 |
| 2017 | 1 | 182 |
| 2018 | 0 | — |
| 2019 | 1 | 26 |
| 2020 | 0 | — |
| 2021 | 1 | 29 |
| 2022 | 0 | — |
| 2023 | 1 | 31 |
| 2024 | 1 | 18 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name G Surgical, LLC took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 84 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent G Surgical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240737 | G Surgical Marksman MIS System | NKB | 2024-04-05 | 18 |
| K230063 | G Surgical Marksman Spinal Deformity System | NKB | 2023-02-09 | 31 |
| K210890 | GPS Cervical Spacers | ODP | 2021-04-23 | 29 |
| K193219 | G Surgical Marksman System | NKB | 2019-12-17 | 26 |
| K171834 | G Surgical OCT Spinal System | NKG | 2017-12-19 | 182 |
| K161516 | G Surgical Marksman MIS System | NKB | 2016-08-25 | 84 |
| K142456 | GPS Spacers | ODP | 2015-04-10 | 220 |
Recalls
openFDA lists no recalls under a recalling firm named G Surgical, LLC.
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 G Surgical, LLC?
FDA lists 7 510(k) clearances under the applicant name “G Surgical, LLC” (first 2015, latest 2024), across 3 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 G Surgical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name G Surgical, LLC is 31 days. Since 2017: 29 days, versus 84 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under G Surgical, LLC?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 4); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2); NKG (Posterior Cervical Screw System, 1).
Next steps
- See all 7 G Surgical, LLC clearances with predicates and recalls
- Run predicate analysis for product code NKB, G Surgical, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.