Cleared Traditional

K964445 - OCTOPUS TISSUE STABILIZER (28001/28002/...

K964445 is the FDA 510(k) clearance for OCTOPUS TISSUE STABILIZER (28001/28002/... by Dlp, Inc.. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K964445 · Dlp, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
85d
Days
Class 1
Risk

K964445 is an FDA 510(k) clearance for the OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006). Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 30, 1997 after a review of 85 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 Dlp, Inc. devices

Submission Details

510(k) Number K964445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date January 30, 1997
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 35
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K964445.
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
K022238 · Medtronic Vascular · Oct 2002
G.E. STERILE ANGIOGRAPHIC TRAY
K960139 · GE Medical Systems · Apr 1996
G.E. STERILE CT BIOPSY TRAY
K960144 · GE Medical Systems · Apr 1996
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
K960143 · GE Medical Systems · Apr 1996
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
K934727 · Cardiac Pacemakers, Inc. · Jan 1994
MODEL 6888 LEAD TUNNELER
K894738 · Cardiac Pacemakers, Inc. · Sep 1989