Cleared Traditional

K001717 - MICOR CONDUCTION CATHETER

K001717 is an FDA 510(k) clearance for MICOR CONDUCTION CATHETER, manufactured by Micor, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K001717 · Micor, Inc. · Anesthesiology device
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Sep 2000
Decision
107d
Days
Class 2
Risk

K001717 is an FDA 510(k) clearance for the MICOR CONDUCTION CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Micor, Inc. (Allison Park, US). The FDA issued a Cleared decision on September 20, 2000 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Micor, Inc. devices

FDA 510(k) Submission Details - K001717

510(k) Number K001717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2000
Decision Date September 20, 2000
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSO Device Classification - Class 2, Special Controls

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSO Catheter, Conduction, Anesthetic

All 52
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K001717.
PERIFIX CATHETER CONNECTOR
K022019 · B.Braun Medical, Inc. · Aug 2002
TE ME NA EPIDURAL CATHETER
K991259 · Te ME NA S.A.R.L. · Feb 2001
SPIROL EPIDURAL CATHETER
K000886 · Abbott Laboratories · Oct 2000
AXIOM MULTIPURPOSE WOUND DRAIN
K993592 · Axiom Medical, Inc. · May 2000
SPRING-WOUND EPIDURAL CATHETER
K991879 · Micor, Inc. · Oct 1999
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17
K992471 · Sims Portex, Inc. · Oct 1999