Cleared Traditional

K020925 - CARBODISSECTING ENDOSCOPE

K020925 is an FDA 510(k) clearance for CARBODISSECTING ENDOSCOPE, manufactured by Endo Surgical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DWX cleared through the Traditional 510(k) pathway after a 404-day FDA review.

K020925 · Endo Surgical Devices, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
404d
Days
Class 2
Risk

K020925 is an FDA 510(k) clearance for the CARBODISSECTING ENDOSCOPE. Classified as Stripper, Artery, Intraluminal (product code DWX), Class II - Special Controls.

Submitted by Endo Surgical Devices, Inc. (Hopkonton, US). The FDA issued a Cleared decision on April 29, 2003 after a review of 404 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Endo Surgical Devices, Inc. devices

FDA 510(k) Submission Details - K020925

510(k) Number K020925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2002
Decision Date April 29, 2003
Days to Decision 404 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 125d · This submission: 404d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWX Device Classification - Class 2, Special Controls

Product Code DWX Stripper, Artery, Intraluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWX Stripper, Artery, Intraluminal

All 8
Devices cleared under the same product code (DWX) and FDA review panel - the closest regulatory comparables to K020925.
MOLLRING MULTITASC
K121415 · LeMaitre Vascular, Inc. · Sep 2012
EXTERNAL VEIN STRIPPER
K933498 · Applied Medical Resources · Mar 1994
MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
K911099 · Pilling Co. · Jun 1991
TRANSLUMINAL ENDARTERECTOMY DEVICE
K904944 · Baxter Healthcare Corp · Dec 1990
OLYMPUS VALVULOTOME W/DETACHABLE TIP
K895878 · Olympus Corp. · Jan 1990
OLYMPUS VALVULOTOME W/FIXED TIP
K894496 · Olympus Corp. · Oct 1989