Chrysalis Intelligence · Sponsors · Acera Surgical, Inc.

Acera Surgical, Inc.

St. Louis, MO, US · 3 510(k) clearances · 1 recalls

Total clearances
3
2020-09-25 → 2025-06-20
Last 12 months
0
Product codes
2
Most recent
2025-06-20
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QSZ 2 2023-05-18
OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery Class II General, Plastic Surgery 1 2025-06-20
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2022-03-21
DateSeverityStatusRecall # ProductCodeReason
2022-03-21 Class II Terminated Z-1030-2022 Restrata, Part Number RWM1-2X2 Misprinted expiration date on the shelf-box
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-06-20 K251224 Restrata Soft Tissue Reinforcement (STR) OXF Class II General, Plastic Surgery
2023-05-18 K223725 Restrata® MiniMatrix QSZ
2020-09-25 K193583 Restrata® QSZ