Cleared Special

K070879 - BARD MALECOT AND PEZZER DRAINS

K070879 is the FDA 510(k) clearance for BARD MALECOT AND PEZZER DRAINS by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FEW) cleared through the Special 510(k) pathway after a 25-day FDA review.

K070879 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
25d
Days
Class 2
Risk

K070879 is an FDA 510(k) clearance for the BARD MALECOT AND PEZZER DRAINS. Classified as Catheter, Malecot (product code FEW), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 24, 2007 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K070879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2007
Decision Date April 24, 2007
Days to Decision 25 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FEW Catheter, Malecot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FEW Catheter, Malecot

Devices cleared under the same product code (FEW) and FDA review panel - the closest regulatory comparables to K070879.
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
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K954147 · Manan Medical Products, Inc. · Mar 1996
OLYMPIC SMART SCALE CARE CENTER
K920423 · Olympic Medical Corp. · Jun 1992