Cleared Traditional

K860991 - SCLEROTHERAPY INJECTION CATHETER

K860991 is an FDA 510(k) clearance for SCLEROTHERAPY INJECTION CATHETER, manufactured by Endovations. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K860991 · Endovations · Gastroenterology & Urology device
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May 1986
Decision
46d
Days
Class 2
Risk

K860991 is an FDA 510(k) clearance for the SCLEROTHERAPY INJECTION CATHETER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 - K860991

510(k) Number K860991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1986
Decision Date May 02, 1986
Days to Decision 46 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
85d faster than avg
Panel avg: 131d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 475
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K860991.
TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
K861618 · Travenol Laboratories, S.A. · Jul 1986
NUTRI-CATH - FEEDING TUBE
K861090 · Gesco Intl., Inc. · Jun 1986
ONE TIME ENTERAL FEEDING BAG
K860818 · Acme United Corp. · May 1986
COMPAT ENTERAL DELIVERY SYSTEMS
K855097 · Sandoz Nutrition · Apr 1986
COMPAT ENTERAL DELIVERY SYSTEMS
K855098 · Sandoz Nutrition · Apr 1986
INFLATOR/DEFLATOR PISTON SYRINGE
K860589 · Microvasive · Apr 1986