# K072684: Mondeal Endoscopic Tissue Recession and Release System

- Pathway: 510(k) (Traditional)
- Applicant: Mondeal North America, Inc.
- Decided: Jan 4, 2008 after 105 days
- Product code: OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered)
- 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
Longest line of descent: 1 generation back to K922391 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925083: Endotrak System, Instratek, Inc. (1993) Summary page 1.
- K922391: Endoscopic Carpal Tunnel Instruments, Instratek, Inc. (1992) Summary page 1.
- K982142: Mountable Endoscopic Knife, A.M. Surgical, Inc. (1998) Summary page 1.

## Indications for use
The intended use of the Mondeal Endoscopic Tissue Recession and Release System is to endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transyerse carpal tunnel ligament. Indications for use: The Mondeal Endoscopic Tissue Release Recession and Release System is indicated for the following: Endoscopic Gastrocnemlus Tenotomy (EGT) - as a tool for tissue recession in patients with heel cord contracture (equinus) who fail to respond to a full course of non-surigcal treatment. Endoscopic Plantar Fasciotorey (EPF) - as a tool for tissue recession in patients with plantar fasciitis who fail to respond to a full course of non-surgical treatment. Carpal Tunnel Release (ECTR)'- as a tool for tissue release in patients who fail to respond to non-surgical treatment of carpal tunnel syndrome.

Source page: https://510kreport.com/device/K072684
Methodology: https://510kreport.com/methodology