Cleared Traditional

K830226 - SURGITEK PERCUTANEOUS NEPHROSTOMY CATH

K830226 · Medical Engineering Corp. · Gastroenterology & Urology device

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Feb 1983

Decision

16d

Days

Risk

K830226 is an FDA 510(k) clearance for the SURGITEK PERCUTANEOUS NEPHROSTOMY CATH. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Medical Engineering Corp. (Walker, US). The FDA issued a Cleared decision on February 9, 1983 after a review of 16 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

FDA 510(k) Submission Details - K830226

510(k) Number	K830226 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 24, 1983
Decision Date	February 09, 1983
Days to Decision	16 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

115d faster than avg

Panel avg: 131d · This submission: 16d

Pathway characteristics

Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code	LJE Catheter, Nephrostomy
Device Class	-

Regulatory Peers - LJE Catheter, Nephrostomy

All 51

Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K830226.

NEPHROSTOMY/BILIARY DRAINAGE BAG

K834476 · Vertex Medical Corp. · Feb 1984

PERCUTANEOUS NEPHROSTOMY CATHETER

K833008 · Medical Engineering Corp. · Oct 1983

URINARY DIVERSION STENT

K830803 · Van-Tec, Inc. · May 1983

HEYER-SCHUTE UNIVERSAL URETERAL STENT

K823418 · American Hospital Supply Corp. · Dec 1982

SURGITEK PERCUTANEOUS NEPHROST. STENT

K821776 · Medical Engineering Corp. · Aug 1982

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K830226

Medical Engineering Corp.

Walker, MI · US

Regulatory profile

28 submissions 28 cleared

100% clearance rate · Active in Gastroenterology & Urology

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: February 9, 1983. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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