# Acera Surgical, Inc.

- Location (FDA's records): St. Louis, MO
- FDA decisions: 8 (2016–2026): 8 510(k) clearances
- Product codes: QSZ (4), GXQ (3), OXF (1)
- 510(k) review time since 2016: median 92 days, against 94 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Johnson & Johnson Professionals, Inc.: 1 (https://510kreport.com/company/johnson-johnson-professionals)
- Collagen Matrix, Inc.: 1 (https://510kreport.com/company/collagen-matrix)
- Kerecis Limited: 1 (https://510kreport.com/company/kerecis)

## Firms that cite its devices most
- Nurami Medical, Ltd.: 1 (https://510kreport.com/company/nurami-medical)
- Beijing Kreate Medical Co., Ltd.: 1 (https://510kreport.com/company/beijing-kreate-medical)
- Huizhou Foryou Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/huizhou-foryou-medical-devices)

## Its most-cited devices
- K170300: Restrata Wound Matrix (2017), cited by 4
- K161278: Cerafix Dura Substitute (2016), cited by 2
- K153613: Cerafix Dura Substitute (2016), cited by 1
- K193583: Restrata® (2020), cited by 1

## Recent decisions
- K261245: Restrata (Oct 16, 2026)
- K251224: Restrata Soft Tissue Reinforcement (STR) (Jun 20, 2025)
- K223725: Restrata® MiniMatrix (May 18, 2023)
- K193583: Restrata® (Sep 25, 2020)
- K172603: Cerafix Dura Substitute (Nov 27, 2017)
- K170300: Restrata Wound Matrix (Apr 26, 2017)
- K161278: Cerafix Dura Substitute (Aug 8, 2016)
- K153613: Cerafix Dura Substitute (Mar 16, 2016)

Source page: https://510kreport.com/company/acera-surgical