Cleared Traditional

K865087 - VAN-TEC DOUBLE SHEATH GRASPING FORCEPS

K865087 is the FDA 510(k) clearance for VAN-TEC DOUBLE SHEATH GRASPING FORCEPS by Van-Tec, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCZ) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K865087 · Van-Tec, Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
85d
Days
Class 2
Risk

K865087 is an FDA 510(k) clearance for the VAN-TEC DOUBLE SHEATH GRASPING FORCEPS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 85 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 K865087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1986
Decision Date March 25, 1987
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCZ Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.
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 - OCZ Endoscopic Grasping/cutting Instrument, Non-powered

All 36
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K865087.
HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 23/12)
K874015 · Endovations · Dec 1987
OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO
K874016 · Endovations · Dec 1987
(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE
K870355 · Cook Urological, Inc. · Apr 1987
DAVOL RETRIEVAL BASKETS & FORCEPS
K845017 · C.R. Bard, Inc. · Jan 1985
LOOP RETRIEVER
K830802 · Van-Tec, Inc. · Apr 1983
RETRIEVABLE FORCEPS
K792345 · Mill-Rose Laboratory · Dec 1979