Cleared Traditional

K900664 - DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES

K900664 is an FDA 510(k) clearance for DISPOSABLE COURNAND, manufactured by Sterimed, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K900664 · Sterimed, Inc. · Cardiovascular device
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Jul 1990
Decision
155d
Days
Class 2
Risk

K900664 is an FDA 510(k) clearance for the DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Sterimed, Inc. (Cartersville, US). The FDA issued a Cleared decision on July 18, 1990 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sterimed, Inc. devices

FDA 510(k) Submission Details - K900664

510(k) Number K900664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date July 18, 1990
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 42
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K900664.
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338 · Arrow Intl., Inc. · Mar 1993
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · E-Z-Em, Inc. · Dec 1991
LAPAROSCOPIC TROCAR
K911483 · United States Endoscopy Group, Inc. · Jul 1991
SELDINGER SINGLE WALL
K895454 · Advance Medical Designs, Inc. · Nov 1989
SELDINGER PERCUTANEOUS 2 PC NEEDLES
K895455 · Advance Medical Designs, Inc. · Nov 1989
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
K893707 · United States Surgical, A Division of Tyco Healthc · Jun 1989