Cleared Traditional

K932273 - CORDIS TUNNELER

K932273 is an FDA 510(k) clearance for CORDIS TUNNELER, manufactured by Cordis Corp.. The device is a Class 1 Neurology device with product code GYK cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K932273 · Cordis Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
102d
Days
Class 1
Risk

K932273 is an FDA 510(k) clearance for the CORDIS TUNNELER. Classified as Instrument, Shunt System Implantation (product code GYK), Class I - General Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4545 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K932273

510(k) Number K932273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1993
Decision Date August 23, 1993
Days to Decision 102 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 148d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

GYK Device Classification - Class 1, General Controls

Product Code GYK Instrument, Shunt System Implantation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4545
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 - GYK Instrument, Shunt System Implantation

All 12
Devices cleared under the same product code (GYK) and FDA review panel - the closest regulatory comparables to K932273.
REIGEL TUNNELING DEVICE
K962761 · Cook, Inc. · Oct 1996
V/P AND L/P CATHETER PASSERS
K934391 · Radionics, Inc. · Nov 1993
PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
K930606 · Pudenz-Schulte Medical Research Corp. · Sep 1993
HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
K895868 · Baxter Healthcare Corp · Oct 1989
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
K883607 · Codman & Shurtleff, Inc. · Sep 1988
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
K873771 · American V. Mueller · Dec 1987