# K020435: Wound Protector/Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Apr 15, 2002 after 66 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954824 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954824: Protector Retractor & Protector Retractor with Drape, Medical Creative Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K070198: Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length Access Retractors,  HAP02 (2007), 0 descendants of its own

## Indications for use
The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.

Source page: https://510kreport.com/device/K020435
Methodology: https://510kreport.com/methodology