Cleared Traditional

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (K962771) - FDA 510(k) Clearance

Class I Cardiovascular device.

K962771 · Pilling Weck, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
126d
Days
Class 1
Risk

K962771 is an FDA 510(k) clearance for the BURKE CONGENITAL THORACOSCOPY INSTRUMENTS. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Pilling Weck, Inc. (Fort Washington, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 126 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 Pilling Weck, Inc. devices

Submission Details

510(k) Number K962771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1996
Decision Date November 19, 1996
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
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 10
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K962771.
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K960143 · GE Medical Systems · Apr 1996
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K844584 · W.L. Gore & Associates, Inc. · Jan 1985
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982