Cleared Traditional

CARBODISSECTING ENDOSCOPE (K020925) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.