Cleared Traditional

K842840 - CURITY SILICONE NEPHROSTOMY CATHETER

K842840 · The Kendal Co. · Gastroenterology & Urology device
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Oct 1984
Decision
76d
Days
-
Risk

K842840 is an FDA 510(k) clearance for the CURITY SILICONE NEPHROSTOMY CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by The Kendal Co. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 The Kendal Co. devices

FDA 510(k) Submission Details - K842840

510(k) Number K842840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date October 04, 1984
Days to Decision 76 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
54d faster than avg
Panel avg: 130d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 50
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K842840.
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K845048 · American Edwards Laboratories · Jan 1985
PERCUTANEOUS NEPHROSTOMY TROCAR SYS
K844090 · American Edwards Laboratories · Dec 1984
E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
K842121 · E-Z-Em, Inc. · Oct 1984
CURITY SUPRAPUBIC DRAINAGE SYSTEM
K842899 · The Kendal Co. · Sep 1984
E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
K841720 · E-Z-Em, Inc. · Jul 1984