Cleared Traditional

K885167 - TRUDELL BENT CATHETER

K885167 is the FDA 510(k) clearance for TRUDELL BENT CATHETER by Sil-Med Corp.. It is a Class 2 Gastroenterology & Urology device (product code FJS) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K885167 · Sil-Med Corp. · Gastroenterology & Urology device
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Jan 1989
Decision
49d
Days
Class 2
Risk

K885167 is an FDA 510(k) clearance for the TRUDELL BENT CATHETER. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on January 31, 1989 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Sil-Med Corp. devices

Submission Details

510(k) Number K885167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1988
Decision Date January 31, 1989
Days to Decision 49 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJS Catheter, Peritoneal, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FJS Catheter, Peritoneal, Long-term Indwelling

All 14
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K885167.
MEDCOMP PERITONEAL DIALYSIS CATHETERS
K915490 · Medical Components, Inc. · Feb 1994
PERITONEAL CATHETERS
K902101 · Akcess Medical Products, Inc. · Jul 1990
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · Quinton, Inc. · Mar 1989
GORE-TEX PERITONEAL CATHETERR
K820909 · W.L. Gore & Associates, Inc. · May 1982
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718 · Quinton, Inc. · Oct 1981
TENCKHOFF PERITONEAL CATHETERS
K812607 · Quinton, Inc. · Oct 1981