Restrata®— 510(k) K193583

Substantially Equivalent

Acera Surgical, Inc.

FDA 510(k) clearance K193583 for Restrata®, Substantially Equivalent on 2020-09-25. Applicant: Acera Surgical, Inc.. Device class: Unclassified.

Clearance details

Applicant: Acera Surgical, Inc.
Product code: Code QSZ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2019-12-23
Decision date: 2020-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QSZ

K261311 — HYALOMATRIX2026-09-02
K254256 — LUOFUCON® Wound Matrix2026-08-18
K260020 — Redermo Wound Matrix2026-04-16
K251567 — NovoSorb BTM2025-06-20
K242149 — NovoSorb® MTX2025-03-05

More clearances from Acera Surgical, Inc.

K251224 — Restrata Soft Tissue Reinforcement (STR)2025-06-20
K223725 — Restrata® MiniMatrix2023-05-18
K172603 — Cerafix Dura Substitute2017-11-27
K170300 — Restrata Wound Matrix2017-04-26
K161278 — Cerafix Dura Substitute2016-08-08

Recalls naming K193583

K-number listed on FDA's recall record

Z-1030-2022 — Restrata, Part Number RWM1-2X2Class II·Terminated·Acera Surgical Inc·20220321

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193583.

Data sourced from openFDA. This site is unofficial and independent of the FDA.