Virtual Incision: FDA clearances and approvals
Virtual Incision has 1 FDA 510(k) clearance (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 160 days. openFDA lists 1 product recall by a recalling firm named Virtual Incision. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 1 | 160 |
Review time against the same product codes
Since 2017, Virtual Incision's cleared 510(k)s took a median 160 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 160 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SAB | Table Mounted Miniaturized Electromechanical Surgical System | 2 | 1 |
Review panels
Most recent Virtual Incision 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260817 | MIRA Surgical System | SAB | 2026-08-20 | 160 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230025 | De Novo | Table Mounted Miniaturized Electromechanical Surgical System | 2024-02-23 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-04-23.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Virtual Incision is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06856707: MIRA Registry Study (Enrolling by invitation, started 2025-04-30)
Frequently asked questions
How many FDA 510(k) clearances does Virtual Incision have?
Virtual Incision has 1 FDA 510(k) clearance (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Virtual Incision's 510(k)s?
The median time from FDA receipt to decision across Virtual Incision's cleared 510(k)s is 160 days.
What devices does Virtual Incision make?
Its most frequent FDA product codes are SAB (Table Mounted Miniaturized Electromechanical Surgical System, 2).
Has Virtual Incision had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Virtual Incision; the most recent began 2025-04-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 1 Virtual Incision clearances with predicates and recalls
- Run predicate analysis for product code SAB, Virtual Incision's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.