# K070198: Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length Access Retractors,  HAP02

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Jun 13, 2007 after 142 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010870 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030824: Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX 7CM,Model LD112, Hakko Medical Co., Ltd. (2003) Summary page 1.
- K020307: Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112, Hakko Shoji Co., Ltd. (2002) Summary page 1.
- K010870: Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70, Model LD113, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.
- K020435: Wound Protector/Retractor, Applied Medical Resources Corp. (2002) Summary page 1.

## Indications for use
The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories and Fixed-Length Access Retractors are indicated for use in procedures where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The device has application in colorectal, urological, gynecologic, and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories. The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories, when used in conjunction with the ENDOPATH DEXTRUS Fixed-Length Access Retractor, is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during minimally invasive surgery. The Fixed-Length Access Retractor, when used independently, is also intended to provide wound retraction and protection against wound contamination during minimally invasive and open surgery.

Source page: https://510kreport.com/device/K070198
Methodology: https://510kreport.com/methodology