# K940967: Modified Endopath Ils

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: May 27, 1994 after 86 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
42 later devices descend from it; 1 cites it directly.
5 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983536: Proximate Curved and Straight Intraluminal Staplers (1998), 41 descendants of its own
- K991030: Proximate HCS Hemorrhoidal Circular Stapler and Accessories (1999), 30 descendants of its own
- K030925: Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01 (2003), 22 descendants of its own
- K090821: Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L (2009), 21 descendants of its own
- K120179: Reach Surgical Staplers (2012), 17 descendants of its own

## Recalls of this device
- Apr 11, 2019 · Class I · Z-1272-2019: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- Apr 11, 2019 · Class I · Z-1274-2019: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- Apr 11, 2019 · Class I · Z-1273-2019: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- Apr 11, 2019 · Class I · Z-1271-2019: The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Source page: https://510kreport.com/device/K940967
Methodology: https://510kreport.com/methodology