# K033269: Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge Reload

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Dec 10, 2003 after 62 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- 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
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ENDOPATH® Linear Cutters and Staplers: named in the summary without a submission number

## Most influential descendants
- K152421: IS4000 Stapler 30 Instrument and Stapler 30 Reloads (2016), 14 descendants of its own
- K170508: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads (2017), 12 descendants of its own
- K173721: SureForm 60 and SureForm 60 Reloads (2018), 6 descendants of its own
- K183224: SureForm 45, SureForm 45 Reloads (2019), 5 descendants of its own
- K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload (2019), 4 descendants of its own

## Indications for use
The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium. The ENDOPATH ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.

Source page: https://510kreport.com/device/K033269
Methodology: https://510kreport.com/methodology