Cleared Traditional

K865086 - WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION...

K865086 is the FDA 510(k) clearance for WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION... by Van-Tec, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K865086 · Van-Tec, Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
70d
Days
Class 2
Risk

K865086 is an FDA 510(k) clearance for the WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 10, 1987 after a review of 70 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 Van-Tec, Inc. devices

Submission Details

510(k) Number K865086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1986
Decision Date March 10, 1987
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 49
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K865086.
NM INJECTION NEEDLES
K902736 · Olympus Corp. · Aug 1990
TRANSENDOSCOPIC ASPIRATION NEEDLE
K883093 · Endovations · Dec 1988
WASHING/INJECTION NEEDLE
K872060 · Endovations · Jul 1987
VARICES INJECTOR
K851952 · Wilson-Cook Medical, Inc. · Jul 1985
ENDOSCOPIC INJECTION NEEDLE
K820973 · Mill-Rose Laboratory · Apr 1982