Cleared Traditional

K990689 - ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE ...

K990689 · Zcv ,Inc. · Gastroenterology & Urology device
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Sep 1999
Decision
184d
Days
-
Risk

K990689 is an FDA 510(k) clearance for the ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Zcv ,Inc. (Edison, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 184 days - an extended review 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: 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 Zcv ,Inc. devices

FDA 510(k) Submission Details - K990689

510(k) Number K990689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1999
Decision Date September 03, 1999
Days to Decision 184 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 130d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

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