510(k) Report

510(k) · Cleared

Cleared

Carbodissecting Endoscope

K020925510(k) TraditionalCleared Apr 29, 2003404-day reviewClass II21 CFR 870.4875

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

Endo Surgical Devices, Inc. · DWX Stripper, Artery, Intraluminal

Cleared on Apr 29, 2003 as substantially equivalent to K013680 (Endo Surgical Devices, Inc., 2002) after a 404-day review. Its family tree reaches back 1 generation to 2002.

Decided
Apr 29, 2003
Review
404 days
Class
Class II
Product code
DWX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K013680 (2002). No later device cites it as a predicate yet.

K013680 · Carbodissecting Endoscope · Endo Surgical Devices, Inc. · 2002200020022004
K013680 · Carbodissecting Endoscope · Endo Surgical Devices, Inc. · 20020
  1. Root · 1 generation backK013680 Carbodissecting EndoscopeEndo Surgical Devices, Inc. · 2002
  2. This deviceK020925 Carbodissecting EndoscopeEndo Surgical Devices, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013680Carbodissecting EndoscopeEndo Surgical Devices, Inc.2002—
0 (this device)K020925Carbodissecting EndoscopeEndo Surgical Devices, Inc.2003—
FIG. 1 — Lineage of K020925, 2002–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K013680Carbodissecting EndoscopeEndo Surgical Devices, Inc.2002—
*—Sobel-Kaplitt-Sawyer Gas Spatula
Named without a submission number
—
*—Moll Ring Cutter
Named without a submission number
—

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?

  • Its one ancestor has no recall.

How does its category compare?

All DWX devices

DWX Stripper, Artery, Intraluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWX

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWX

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

Recalls per year · DWX

No recall names DWX since 2007.

Adverse event reports per year · DWX

1in 2021

2008: 22009: 12011: 22012: 12017: 12018: 12020: 12021: 1
2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code DWX, 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—00
20080—02
20090—01
20100—00
20110—02
20121—01
20130—00
20140—00
20150—00
20160—00
20170—01
20180—01
20190—00
20200—01
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Carbodissecting Endoscope is designed for use in intraluminal tissue separation during a fenioro-popliteal endarterectomy procedure intended to achieve vascular reconstruction. The device is an adjunctive aid in the separation of vessel layers.

Indications for use as stated in the FDA summary.

More from Endo Surgical Devices, Inc.

2 FDA decisions under this applicant name. See the company

  • K013680Carbodissecting EndoscopeEndo Surgical Devices, Inc. · 2002

Recent decisions in DWX

The DWX category page

  • K121415Mollring MultitascLeMaitre Vascular, Inc. · 2012
  • K032105Endohelix Endarterectomy DeviceEndarx, Inc. · 2003
  • K003719Vascular Architects Periscope DeviceVascular Architects, Inc. · 2001
  • K950813Mollring CutterCardio Vascular Concepts, Inc. · 1995
  • K933498External Vein StripperApplied Medical Resources · 1994

https://510kreport.com/device/K020925 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020925: Carbodissecting Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020925

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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