Cleared Traditional

GELBFISH ENDO-VAC SYSTEM (K970233) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970233 · Gary A. Gelbfish · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
260d
Days
Class 2
Risk

K970233 is an FDA 510(k) clearance for the GELBFISH ENDO-VAC SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Gary A. Gelbfish (Rockville, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 260 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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 Gary A. Gelbfish devices

Submission Details

510(k) Number K970233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 21, 1997
Decision Date October 08, 1997
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - MCW Catheter, Peripheral, Atherectomy

All 40
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