Cleared Traditional

K894756 - DENVER PERITONEO-VENUS SHUNT

K894756 is an FDA 510(k) clearance for DENVER PERITONEO-VENUS SHUNT, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPM cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K894756 · Codman & Shurtleff, Inc. · Gastroenterology & Urology device
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Sep 1989
Decision
64d
Days
Class 2
Risk

K894756 is an FDA 510(k) clearance for the DENVER PERITONEO-VENUS SHUNT. Classified as Shunt, Peritoneal (product code KPM), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on September 29, 1989 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5955 - the FDA gastroenterology and urology device 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 Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K894756

510(k) Number K894756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date September 29, 1989
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 131d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPM Device Classification - Class 2, Special Controls

Product Code KPM Shunt, Peritoneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5955
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 - KPM Shunt, Peritoneal

All 9
Devices cleared under the same product code (KPM) and FDA review panel - the closest regulatory comparables to K894756.
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
K973129 · Denver Biomaterials, Inc. · Mar 1998
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K962814 · Denver Biomaterials, Inc. · Apr 1997
LEVEEN PERITINEO-VENOUS SHUNT
K901360 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
DENVER PLEURO-PERITONEAL SHUNT
K880570 · Codman & Shurtleff, Inc. · Jun 1988
DENVER PERITONEO-VENOUS SHUNT
K880401 · Codman & Shurtleff, Inc. · May 1988
CORDIS HAKIM ASCITES VALVE SYSTEM
K803258 · Cordis Corp. · Jan 1981