Cleared Traditional

K936247 - MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES

K936247 is an FDA 510(k) clearance for MEDICON INSTRUMENTS TROCARS, manufactured by Medicon Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K936247 · Medicon Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
140d
Days
Class 2
Risk

K936247 is an FDA 510(k) clearance for the MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Medicon Instruments, Inc. (Washington, US). The FDA issued a Cleared decision on May 19, 1994 after a review of 140 days - within the typical 510(k) review window.

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 Medicon Instruments, Inc. devices

FDA 510(k) Submission Details - K936247

510(k) Number K936247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date May 19, 1994
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 K936247.
HEARTPORT THORACIC TROCAR
K964302 · Heartport, Inc. · May 1997
HEARTPORT NEEDLE TROCAR
K965051 · Heartport, Inc. · Mar 1997
GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE
K951448 · Global Medical Products, Ltd. · Mar 1996
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