Cleared Traditional

ROTARY VASCULAR KNIFE (K833547) - FDA 510(k) Clearance

Class I Cardiovascular device.

K833547 · Formedco, Inc. · Cardiovascular device
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Jan 1984
Decision
106d
Days
Class 1
Risk

K833547 is an FDA 510(k) clearance for the ROTARY VASCULAR KNIFE. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Formedco, Inc. (Walker, US). The FDA issued a Cleared decision on January 26, 1984 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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 Formedco, Inc. devices

Submission Details

510(k) Number K833547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 26, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
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 - DWS Instruments, Surgical, Cardiovascular

All 13
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K833547.
G.E. STERILE CT BIOPSY TRAY
K960144 · GE Medical Systems · Apr 1996
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
K960143 · GE Medical Systems · Apr 1996
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980
CASTROVIEJO VASCULAR SCISSORS
K792576 · Edward Weck, Inc. · Dec 1979