Cleared Traditional

K801818 - TENCKHOFF CATHETER

K801818 is an FDA 510(k) clearance for TENCKHOFF CATHETER, 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 84-day FDA review.

K801818 · Sil-Med Corp. · Gastroenterology & Urology device
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Oct 1980
Decision
84d
Days
Class 2
Risk

K801818 is an FDA 510(k) clearance for the TENCKHOFF CATHETER. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Sil-Med Corp. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 84 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

FDA 510(k) Submission Details - K801818

510(k) Number K801818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1980
Decision Date October 23, 1980
Days to Decision 84 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
47d faster than avg
Panel avg: 131d · This submission: 84d
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 K801818.
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718 · Quinton, Inc. · Oct 1981
TENCKHOFF PERITONEAL CATHETERS
K812607 · Quinton, Inc. · Oct 1981
MIROMED PERITONEAL DIALYSIS CATHETER
K810236 · American Medical Products, Inc. · Mar 1981
BETA-CAP II
K801679 · Quinton, Inc. · Oct 1980
BETA CAP SYSTEM
K780449 · Quinton, Inc. · May 1978
SHADOW-CATHS
K780643 · Quinton, Inc. · Apr 1978