Cleared Traditional

K970159 - FLEX-NECK PD CATHETER

K970159 is an FDA 510(k) clearance for FLEX-NECK PD CATHETER, manufactured by Janin Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K970159 · Janin Group, Inc. · Gastroenterology & Urology device
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Sep 1997
Decision
232d
Days
Class 2
Risk

K970159 is an FDA 510(k) clearance for the FLEX-NECK PD CATHETER. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Janin Group, Inc. (Aurora, US). The FDA issued a Cleared decision on September 5, 1997 after a review of 232 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Janin Group, Inc. devices

FDA 510(k) Submission Details - K970159

510(k) Number K970159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1997
Decision Date September 05, 1997
Days to Decision 232 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
101d slower than avg
Panel avg: 131d · This submission: 232d
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 K970159.
PD CATH
K053123 · Med-Conduit, Inc. · Mar 2006
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
K993149 · Medionics International, Inc. · Apr 2000
ASH ADVANTAGE PERITONEAL CATHETER
K991042 · Janin Group, Inc. · Jun 1999
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392 · Sil-Med Corp. · Jul 1997
MEDCOMP PERITONEAL DIALYSIS CATHETERS
K915490 · Medical Components, Inc. · Feb 1994
PERITONEAL CATHETERS
K902101 · Akcess Medical Products, Inc. · Jul 1990