Cleared Traditional

K802079 - DEKNATEL GOOSEN VASCULAR PUNCH BLADES

K802079 is the FDA 510(k) clearance for DEKNATEL GOOSEN VASCULAR PUNCH BLADES by Howmedica Corp.. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K802079 · Howmedica Corp. · Cardiovascular device
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Sep 1980
Decision
19d
Days
Class 1
Risk

K802079 is an FDA 510(k) clearance for the DEKNATEL GOOSEN VASCULAR PUNCH BLADES. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Howmedica Corp. (Walker, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 19 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Corp. devices

Submission Details

510(k) Number K802079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1980
Decision Date September 16, 1980
Days to Decision 19 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
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 32
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K802079.
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · Imm Enterprises , Ltd. · Apr 1984
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982
CASTROVIEJO VASCULAR SCISSORS
K792576 · Edward Weck, Inc. · Dec 1979
AORTIC OCCLUDER #000390
K792088 · Edward Weck, Inc. · Oct 1979
CARDIOVASCULAR INSTRUMENTS-VARIOUS
K791710 · Edward Weck, Inc. · Sep 1979