# K061425: Purewrist Scissors, Model PW1101-01;Purewrist Dissector,  Model PW1201-01;Purewrist Hook, Model PW1301-01

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Endoscopic Devices
- Decided: Aug 10, 2006 after 79 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910831 (1991). 2 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.

## Most influential descendants
- K173919: HX Device (2018), 8 descendants of its own
- K203603: Monopolar Hook (2021), 3 descendants of its own
- K173405: DiLumen Endolumenal Interventional Scissors (DiLumen Is) (2018), 1 descendant of its own
- K260183: MediBot Needle Driver Uno (2026), 0 descendants of its own
- K243968: Revolve Surgical System (2025), 0 descendants of its own

## Recalls of this device
- May 20, 2011 · Not classified · Z-2743-2011: PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors
- May 20, 2011 · Not classified · Z-2744-2011: PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors

## Indications for use
The pureWrist™ electrocautery laparoscopic 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/K061425
Methodology: https://510kreport.com/methodology