Cleared Traditional

K000704 - DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

K000704 is an FDA 510(k) clearance for DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS), manufactured by Dmc Medical, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K000704 · Dmc Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
78d
Days
Class 1
Risk

K000704 is an FDA 510(k) clearance for the DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS). Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Dmc Medical, Ltd. (Fullerton, US). The FDA issued a Cleared decision on May 19, 2000 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dmc Medical, Ltd. devices

FDA 510(k) Submission Details - K000704

510(k) Number K000704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2000
Decision Date May 19, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBX Catheter, Irrigation

All 42
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K000704.
MISONIX IRRIGATION SYSTEM MOEDL BC20P
K013417 · Misonix, Inc. · Jan 2002
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703 · Allegiance Healthcare Corp. · Dec 1997
ULTRACELL SUCTION SPONGE
K972635 · Ultracell Medical Technologies, Inc. · Oct 1997
FLAT CLOSED WOUND DRAIN WITH TROCAR
K965146 · Axiom Medical, Inc. · Mar 1997
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
K961295 · Sil-Med Corp. · Jun 1996
CLOSED FLUID COLLECTION SYSTEM
K961147 · B.Braun Medical, Inc. · May 1996