Chrysalis Intelligence · Sponsors · Virtual Incision

Virtual Incision

Lincoln, NE, US · 2 510(k) clearances · 1 recalls

Total clearances
2
2024-02-23 → 2026-08-20
Last 12 months
1
Product codes
1
Most recent
2026-08-20
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
SAB Table Mounted Miniaturized Electromechanical Surgical System Class II General, Plastic Surgery 2 2026-08-20
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2025-04-23
DateSeverityStatusRecall # ProductCodeReason
2025-04-23 Class II Completed Z-1905-2025 MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Softwar… — The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen…
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2026-08-20 K260817 MIRA Surgical System SAB Class II General, Plastic Surgery
2024-02-23 DEN230025 MIRA Surgical System SAB Class II General, Plastic Surgery