510(k) Report

510(k) · Cleared

Cleared

Mondeal Endoscopic Tissue Recession and Release System

K072684510(k) TraditionalCleared Jan 4, 2008105-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mondeal North America, Inc. · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

Cleared on Jan 4, 2008 as substantially equivalent to K925083 (Instratek, Inc., 1993) and 2 other predicates after a 105-day review. Its family tree reaches back 1 generation to 1992.

Decided
Jan 4, 2008
Review
105 days
Class
Class II
Product code
OCZ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K922391 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1993: 1 other ancestorK922391 · Endoscopic Carpal Tunnel Instruments · Instratek, Inc. · 1992 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors K922391 · Endoscopic Carpal Tunnel Instruments · Instratek, Inc. · 1992 · recalled0
  1. Root · 1 generation backK922391 Endoscopic Carpal Tunnel InstrumentsInstratek, Inc. · 1992 · Recalled
  2. This deviceK072684 Mondeal Endoscopic Tissue Recession and Release SystemMondeal North America, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922391Endoscopic Carpal Tunnel InstrumentsInstratek, Inc.19922
0 (this device)K072684Mondeal Endoscopic Tissue Recession and Release SystemMondeal North America, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199810
FIG. 1 — Lineage of K072684, 1992–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OCZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OCZ device

  1. #1 K252800 KARL STORZ Endoscopic Accessories for Urologyscore 11.5 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K925083Endotrak System
Summary page 1
…Sec. 876.1500) DEVICE PRODUCT CODE: fXZ EMF SUBSEQUENT PRODUCT CODE: 'KOG SUBSTANTIALLY EQUIVALENT DEVICES Instratek EndoTrack System (K925083) Instratek Endoscopic Carpal Tunnel Instrument (K922391) A.M. Surgical Mountabl…
Instratek, Inc.1993—
*K922391Endoscopic Carpal Tunnel Instruments
Summary page 1
…: 'KOG SUBSTANTIALLY EQUIVALENT DEVICES Instratek EndoTrack System (K925083) Instratek Endoscopic Carpal Tunnel Instrument (K922391) A.M. Surgical Mountable Endoscopic Knife (K982142) DEVICE DESCRIPTION: The…
Instratek, Inc.19922
*K982142Mountable Endoscopic Knife
Summary page 1
…rack System (K925083) Instratek Endoscopic Carpal Tunnel Instrument (K922391) A.M. Surgical Mountable Endoscopic Knife (K982142) DEVICE DESCRIPTION: The Mondeal Endoscopic Tissue Recession and Release System is a…
A.M. Surgical, Inc.1998—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.

How does its category compare?

All OCZ devices

OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OCZ

1in 2024

2008: 12010: 12011: 12012: 12014: 22015: 12016: 12020: 12024: 12026 (partial year): 1
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCZ

Too few OCZ 510(k)s in any year since 2007 to give a median.

Recalls per year · OCZ

17in 2022

2022: 17
2007high 17 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCZ

34in 2025

2007: 12008: 22009: 22010: 22012: 62013: 42014: 12015: 2422016: 7592017: 7342018: 2522019: 152020: 212021: 202022: 332023: 252024: 372025: 34
2007high 759 (2016) · low 0 (2011)2025

MAUDE reports naming product code OCZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20081—02
20090—02
20101—02
20111—00
20121—06
20130—04
20142—01
20151—0242
20161—0759
20170—0734
20180—0252
20190—015
20201—021
20210—020
20220—1733
20230—025
20241—037
20250—034
20261—0—

What is it indicated for?

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)…

Read the full statement (128 words)

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.

Indications for use as stated in the FDA summary.

Recent decisions in OCZ

The OCZ category page

  • K252800KARL STORZ Endoscopic Accessories for UrologyKarl Storz SE & CO. KG · 2026
  • K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)Envision Endoscopy · 2024
  • K191900Single Use Grasping ForcepsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2020
  • K152802Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2016
  • K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015

https://510kreport.com/device/K072684 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072684: Mondeal Endoscopic Tissue Recession and Release System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072684

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026