Cleared Traditional

K973183 - WOUND DRAINAGE HOLDER

K973183 is an FDA 510(k) clearance for WOUND DRAINAGE HOLDER, manufactured by R & D Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGZ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K973183 · R & D Medical Products, Inc. · General & Plastic Surgery device
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Jan 1998
Decision
151d
Days
Class 1
Risk

K973183 is an FDA 510(k) clearance for the WOUND DRAINAGE HOLDER. Classified as Accessories, Catheter (product code KGZ), Class I - General Controls.

Submitted by R & D Medical Products, Inc. (Irvine, US). The FDA issued a Cleared decision on January 23, 1998 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all R & D Medical Products, Inc. devices

FDA 510(k) Submission Details - K973183

510(k) Number K973183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1997
Decision Date January 23, 1998
Days to Decision 151 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 115d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

KGZ Device Classification - Class 1, General Controls

Product Code KGZ Accessories, Catheter
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 - KGZ Accessories, Catheter

All 18
Devices cleared under the same product code (KGZ) and FDA review panel - the closest regulatory comparables to K973183.
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
K974295 · Byron Medical · Feb 1998
PALESTRANT IRRIGATION AND DRAINAGE SET
K896087 · North American Instrument Corp. · Nov 1989
OPTICAL CATHETER(TM) INTRODUCER SETS
K895041 · Medical Dynamics, Inc. · Oct 1989
DESERET PRN ADAPTER
K893406 · Deseret Medical, Inc. · Jun 1989
CONCEPT SWITCHING STICK
K873009 · Concept, Inc. · Aug 1987
ANGIO MED DISPOSABLE PRESSURE CONNECTORS
K855078 · Angiomed U.S., Inc. · Feb 1986