# K200559: CarpX

- Pathway: 510(k) (Traditional)
- Applicant: Pavmed, Inc.
- Decided: Apr 20, 2020 after 48 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982142 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080133: Mountable Endoscopic Blade, A.M. Surgical, Inc. (2008) Summary page 4.

## Indications for use
The CarpX is indicated for the minimally invasive isolation and incision/divison of ligaments, tendons, or fascia such as the transverse carpal ligament for treatment of carpal tunnel syndrome.

Source page: https://510kreport.com/device/K200559
Methodology: https://510kreport.com/methodology