Cleared Traditional

K862424 - STEERABLE CATHETER SYSTEM

K862424 is an FDA 510(k) clearance for STEERABLE CATHETER SYSTEM, manufactured by Endovations. The device is a Class 2 Gastroenterology & Urology device with product code GCP cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K862424 · Endovations · Gastroenterology & Urology device
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Sep 1986
Decision
88d
Days
Class 2
Risk

K862424 is an FDA 510(k) clearance for the STEERABLE CATHETER SYSTEM. Classified as Endoscope, Ac-powered And Accessories (product code GCP), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on September 22, 1986 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Endovations devices

FDA 510(k) Submission Details - K862424

510(k) Number K862424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1986
Decision Date September 22, 1986
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCP Device Classification - Class 2, Special Controls

Product Code GCP Endoscope, Ac-powered And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCP Endoscope, Ac-powered And Accessories

All 9
Devices cleared under the same product code (GCP) and FDA review panel - the closest regulatory comparables to K862424.
EOS BRAND DISPOSABLE PROCTOSCOPE
K954614 · North Eos Industries, Inc. · Apr 1996
PORGES UNIVERSAL HANDLES
K896505 · Porges Corp. · Jan 1990
MODEL 6500 MERCURY ARC LIGHT SOURCE
K896008 · Medical Dynamics, Inc. · Dec 1989
TAMPONADE BALLOON CUFF
K833859 · American Endoscopy, Inc. · Jan 1984
CCD ENDOSCOPE AND ATTACHMENTS
K801247 · Welch Allyn, Inc. · Jul 1980
ENDOSCOPE AND ACCESSORIES
K790071 · Olympus Corp. · Apr 1979