510(k) Report

FDA applicant

Acera Surgical, Inc.

St. Louis, MO8 decisions2016–20261 recall

FDA records 8 decisions for Acera Surgical, Inc. (St. Louis, MO) from 2016 to 2026: 8 510(k) clearances. Most are in product codes QSZ (Absorbable Synthetic Wound Dressing) and GXQ (Dura Substitute). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Acera Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 22017: 22020: 12023: 12025: 12026 (partial year): 1
2016high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2016high 1 (2022) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Acera Surgical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Acera Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QSZAbsorbable Synthetic Wound Dressing4decisions
  • GXQDura Substitute3decisions
  • OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 92 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 94 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170300Restrata Wound MatrixAcera Surgical, Inc. · 20174cite it
  • K161278Cerafix Dura SubstituteAcera Surgical, Inc. · 20162cite it
  • K153613Cerafix Dura SubstituteAcera Surgical, Inc. · 20161cites it
  • K193583Restrata®Acera Surgical, Inc. · 20201cites it

What has FDA decided for it lately?

  • K261245RestrataAcera Surgical, Inc. · 2026
  • K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. · 2025
  • K223725Restrata® MiniMatrixAcera Surgical, Inc. · 2023
  • K193583Restrata®Acera Surgical, Inc. · 20201 recall
  • K172603Cerafix Dura SubstituteAcera Surgical, Inc. · 2017
  • K170300Restrata Wound MatrixAcera Surgical, Inc. · 20171 recall
  • K161278Cerafix Dura SubstituteAcera Surgical, Inc. · 2016
  • K153613Cerafix Dura SubstituteAcera Surgical, Inc. · 2016

All 8 as Acera Surgical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K170300Restrata, Part Number RWM1-2X2Mar 21, 2022Class II