Cleared Traditional

K860337 - VAN-TEC URETERAL ANESTHE. STONE DISPLAC...

K860337 is the FDA 510(k) clearance for VAN-TEC URETERAL ANESTHE. STONE DISPLAC... by Van-Tec, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K860337 · Van-Tec, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
55d
Days
Class 2
Risk

K860337 is an FDA 510(k) clearance for the VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 25, 1986 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Van-Tec, Inc. devices

Submission Details

510(k) Number K860337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1986
Decision Date March 25, 1986
Days to Decision 55 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
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 115
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K860337.
FOLEY CATHETERS
K863517 · Instrumentation Industries, Inc. · Oct 1986
MODIFIED FOLEY CATHETER
K863302 · Sheridan Catheter Corp. · Oct 1986
NORTA TEFLON COATED LATEX BALLOON CATHETERS
K861181 · Beiersdorf, Inc. · Apr 1986
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
K860484 · The Kendal Co. · Mar 1986
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP
K852084 · The Kendal Co. · Sep 1985
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
K853207 · American Pharmaseal Div. Ahsc · Sep 1985