# K984240: Endopath Endoscopic Instruments

- Pathway: 510(k) (Abbreviated)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Jun 22, 1999 after 207 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910831 (1991). 1 ancestor in all.
38 later devices descend from it; 13 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910831: Endopath Surgical Instruments, Symbiosis Corp. (1991) Summary page 1.

## Most influential descendants
- K061425: Purewrist Scissors, Model PW1101-01;Purewrist Dissector,  Model PW1201-01;Purewrist Hook, Model PW1301-01 (2006), 14 descendants of its own
- K173919: HX Device (2018), 8 descendants of its own
- K061417: Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 (2006), 6 descendants of its own
- K043541: Endolink True Movement System (2005), 4 descendants of its own
- K203603: Monopolar Hook (2021), 3 descendants of its own

## Recalls of this device
- Nov 6, 2007 · Not classified · Z-0565-2008: Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.

## Indications for use
The ENDOPATH Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

Source page: https://510kreport.com/device/K984240
Methodology: https://510kreport.com/methodology