Cleared Traditional

K970201 - GSI CANNULA WITH INTRODUCER

K970201 is an FDA 510(k) clearance for GSI CANNULA WITH INTRODUCER, manufactured by General Surgical Innovations. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K970201 · General Surgical Innovations · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
90d
Days
Class 2
Risk

K970201 is an FDA 510(k) clearance for the GSI CANNULA WITH INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by General Surgical Innovations (Palo Alto, US). The FDA issued a Cleared decision on April 21, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 General Surgical Innovations devices

FDA 510(k) Submission Details - K970201

510(k) Number K970201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date April 21, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 497
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K970201.
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K964814 · Bipore, Inc. · May 1997
TRANSJUGULAR ACCESS SET
K964034 · AngioDynamics, Inc. · May 1997
EVS
K963886 · Applied Medical Resources · Apr 1997
CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
K962978 · Johnson & Johnson Medical, Inc. · Jan 1997
HEMODIALYSIS INTRODUCER SET
K961780 · Thomas Medical Products, Inc. · Dec 1996
CATH SEAL
K962180 · Universal Medical Instrument Corp. · Nov 1996