Cleared Traditional

K861469 - DUTHOY STONE BASKET

K861469 is an FDA 510(k) clearance for DUTHOY STONE BASKET, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K861469 · Lake Region Mfg., Inc. · Gastroenterology & Urology device
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May 1986
Decision
23d
Days
Class 2
Risk

K861469 is an FDA 510(k) clearance for the DUTHOY STONE BASKET. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on May 15, 1986 after a review of 23 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K861469

510(k) Number K861469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date May 15, 1986
Days to Decision 23 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
107d faster than avg
Panel avg: 130d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFL Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K861469.
VAN-TEC POSITIVE OPEN SEGURA BASKET
K870615 · Van-Tec, Inc. · Mar 1987
SEGURA DRETLER BASKET
K864874 · Van-Tec, Inc. · Mar 1987
4-WIRE (CARSON) STONE EXTRACTOR
K863081 · Cook Urological, Inc. · Oct 1986
VAN-TEC DEFLECTING GRASPING FORCEPS
K860268 · Van-Tec, Inc. · Apr 1986
DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER
K860946 · Van-Tec, Inc. · Apr 1986
VAN-TEC DEFLECTING LOOP RETRIEVER
K860269 · Van-Tec, Inc. · Mar 1986