Cleared Traditional

K821776 - SURGITEK PERCUTANEOUS NEPHROST. STENT (FDA 510(k) Clearance)

K821776 · Medical Engineering Corp. · Gastroenterology & Urology device
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Aug 1982
Decision
54d
Days
-
Risk

K821776 is an FDA 510(k) clearance for the SURGITEK PERCUTANEOUS NEPHROST. STENT. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Medical Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1982 after a review of 54 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 Medical Engineering Corp. devices

Submission Details

510(k) Number K821776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1982
Decision Date August 10, 1982
Days to Decision 54 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 130d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 55
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