Cleared Traditional

K941839 - DISPOSABLE SURGICAL CABLE

K941839 is an FDA 510(k) clearance for DISPOSABLE SURGICAL CABLE, manufactured by Conmed Andover Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K941839 · Conmed Andover Medical, Inc. · Cardiovascular device
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Jul 1994
Decision
105d
Days
Class 2
Risk

K941839 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL CABLE. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Conmed Andover Medical, Inc. (Haverhill, US). The FDA issued a Cleared decision on July 27, 1994 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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 Conmed Andover Medical, Inc. devices

FDA 510(k) Submission Details - K941839

510(k) Number K941839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1994
Decision Date July 27, 1994
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 79
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K941839.
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K960446 · Medtronic Vascular · May 1996
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
K952659 · Tronomed, Inc. · Jan 1996
CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES
K945034 · Conmedcorp · Oct 1994
CONMED ECG PATIENT CABLES AND LEADWIRES
K933649 · Conmedcorp · Feb 1994
DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
K922009 · Remington Medical, Inc. · Feb 1993
MODEL 4280 SURGICAL EXTENSION CABLE
K922899 · Pace Medical · Dec 1992