Cleared Special

Restrata® (K193583) - FDA 510(k) Clearance

K193583 · Acera Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
277d
Days
-
Risk

K193583 is an FDA 510(k) clearance for the Restrata®. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 25, 2020 after a review of 277 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Acera Surgical, Inc. devices

Submission Details

510(k) Number K193583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date September 25, 2020
Days to Decision 277 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 115d · This submission: 277d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QSZ Absorbable Synthetic Wound Dressing
Device Class -
Definition Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.

Regulatory Consultant

Secure Biomed Evalutations
Linda Braddon

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QSZ Absorbable Synthetic Wound Dressing

All 10
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K193583.
Restrata® MiniMatrix
K223725 · Acera Surgical, Inc. · May 2023
SiOxD Wound Matrix
K222189 · Sioxmed, LLC · Nov 2022
NovoSorb Matrix
K221686 · Polynovo Biomaterials Pty, Ltd. · Sep 2022
Phoenix Wound Matrix
K173544 · Nanofiber Solutions, Inc. · Mar 2018
GORE BIO-A WOUND MATRIX
K132397 · W.L. Gore & Associates, Inc. · May 2014