Cleared Traditional

K961392 - ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II

K961392 is an FDA 510(k) clearance for ANTIMICROBIAL PERITONEAL DIALYSIS COIL ..., manufactured by Sil-Med Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 463-day FDA review.

K961392 · Sil-Med Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
463d
Days
Class 2
Risk

K961392 is an FDA 510(k) clearance for the ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II. 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 July 18, 1997 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Sil-Med Corp. devices

FDA 510(k) Submission Details - K961392

510(k) Number K961392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1996
Decision Date July 18, 1997
Days to Decision 463 days
Submission Type Traditional
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
332d slower than avg
Panel avg: 131d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJS Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K961392.
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
K993149 · Medionics International, Inc. · Apr 2000
ASH ADVANTAGE PERITONEAL CATHETER
K991042 · Janin Group, Inc. · Jun 1999
FLEX-NECK PD CATHETER
K970159 · Janin Group, Inc. · Sep 1997
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