# K070859: Reprocessed Ethicon Ets Endoscopic Linear Cutters

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Sep 12, 2007 after 168 days
- Product code: NLL (Staple, Implantable, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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 K821994 (1982). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961390: Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter, Ethicon Endo-Surgery, Inc. (1996) Summary page 1.
- K980023: Endopath and Proximate Linear Cutters, Ethicon Endo-Surgery, Inc. (1998) Summary page 1.
- K002398: Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets Compact-FLEX45 NO-Knife Articulating, Ethicon Endo-Surgery, Inc. (2000) Summary page 1.
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002). Our reading of the summary gave K020079, FDA’s number for Bladeworks Microkeratome Blade, Model 7061 (Blade Works, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ethicon Endopath ETS Endoscopic Linear Cutter and ETS-Flex…”.

## Indications for use
The ETS 45, ETS-Flex45, and Compact-Flex 45 reprocessed, reloadable Endoscopic Linear Cutters are intended for transection, resection and/or anastomosis. These instruments have applications in open and minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic and pediatric surgery. The ETS Flex 45, ETS 45 and ETS Compact Flex 45 device can be used with staple line or tissue buttressing materials such as bovine pericardium. The ETS and ETS-Flex (articulating) reprocessed, reloadable Endoscopic Linear Cutters (35mran) have applications in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

Source page: https://510kreport.com/device/K070859
Methodology: https://510kreport.com/methodology