# K223377: BIASURGE Advanced Surgical Solution

- Pathway: 510(k) (Traditional)
- Applicant: Rochal Technologies, LLC
- Decided: Mar 30, 2023 after 146 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914579 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160192: Atteris Antimicrobial Skin & Wound Cleanser, Rochal Industries, LLC (2016) Summary page 6.

## Indications for use
Biasurge Advanced Surgical Solution is indicated for use in mechanical cleansing and removal of debris, including microorganisms from wounds.

Source page: https://510kreport.com/device/K223377
Methodology: https://510kreport.com/methodology