Cleared Traditional

K864874 - SEGURA DRETLER BASKET

K864874 is the FDA 510(k) clearance for SEGURA DRETLER BASKET by Van-Tec, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFL) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K864874 · Van-Tec, Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
88d
Days
Class 2
Risk

K864874 is an FDA 510(k) clearance for the SEGURA DRETLER BASKET. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), 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 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 K864874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1986
Decision Date March 10, 1987
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFL Dislodger, Stone, Basket, Ureteral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 - FFL Dislodger, Stone, Basket, Ureteral, Metal

All 25
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K864874.
HELICAL STONE BASKET (DISPOSABLE)
K871779 · Van-Tec, Inc. · Jun 1987
VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH
K870696 · Van-Tec, Inc. · Mar 1987
VAN-TEC POSITIVE OPEN SEGURA BASKET
K870615 · Van-Tec, Inc. · Mar 1987
4-WIRE (CARSON) STONE EXTRACTOR
K863081 · Cook Urological, Inc. · Oct 1986
DUTHOY STONE BASKET
K861469 · Lake Region Mfg., Inc. · May 1986
VAN-TEC DEFLECTING GRASPING FORCEPS
K860268 · Van-Tec, Inc. · Apr 1986