Cleared Traditional

K870679 - VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE

K870679 is the FDA 510(k) clearance for VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE by Van-Tec, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FBO) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K870679 · Van-Tec, Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
39d
Days
Class 2
Risk

K870679 is an FDA 510(k) clearance for the VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE. Classified as Cystourethroscope (product code FBO), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 30, 1987 after a review of 39 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 K870679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1987
Decision Date March 30, 1987
Days to Decision 39 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
91d faster than avg
Panel avg: 130d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBO Cystourethroscope
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 - FBO Cystourethroscope

All 14
Devices cleared under the same product code (FBO) and FDA review panel - the closest regulatory comparables to K870679.
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
K945185 · KARL STORZ Endoscopy-America, Inc. · May 1995
KSEA CONTINOUS FLOW CYSTOSCOPE
K943668 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
CONTINUOUS IRRIGATION CYSTOURETHROSCOPE
K935163 · Richard Wolf Medical Instruments Corp. · Sep 1994
OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE
K843084 · Olympus Corp. · Jan 1985