G Surgical, LLC
G Surgical, LLC appears in FDA public data with 0 recalls, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Mar 1, 2023 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Apr 5, 2024.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Known Names
G Surgical, G Surgical Co
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 1, 2023 | Austin, TX | Devices | No Action Indicated (NAI) | 3009169872 |
| May 17, 2018 | Austin, TX | Devices | No Action Indicated (NAI) | 3009169872 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K240737 | G Surgical Marksman MIS System | Apr 5, 2024 |
| K230063 | G Surgical Marksman Spinal Deformity System | Feb 9, 2023 |
| K210890 | GPS Cervical Spacers | Apr 23, 2021 |
| K193219 | G Surgical Marksman System | Dec 17, 2019 |
| K171834 | G Surgical OCT Spinal System | Dec 19, 2017 |
| K161516 | G Surgical Marksman MIS System | Aug 25, 2016 |
| K142456 | GPS Spacers | Apr 10, 2015 |