# K193583: Restrata®

- Pathway: 510(k) (Special)
- Applicant: Acera Surgical, Inc.
- Decided: Sep 25, 2020 after 277 days
- Product code: QSZ (Absorbable Synthetic Wound Dressing)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K842066 (1985). 82 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170300: Restrata Wound Matrix, Acera Surgical, Inc. (2017) Summary page 5.

## Most influential descendants
- K223725: Restrata® MiniMatrix (2023), 0 descendants of its own

## Recalls of this device
- Mar 21, 2022 · Class II · Z-1030-2022: Misprinted expiration date on the shelf-box

## Indications for use
Restrata® is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced wounds), trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.

Source page: https://510kreport.com/device/K193583
Methodology: https://510kreport.com/methodology