Cleared Traditional

K914505 - STONE BASKET

K914505 is an FDA 510(k) clearance for STONE BASKET, manufactured by Surgitek Medical Engineering Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K914505 · Surgitek Medical Engineering Corp. · Gastroenterology & Urology device
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Dec 1991
Decision
61d
Days
Class 2
Risk

K914505 is an FDA 510(k) clearance for the STONE BASKET. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Surgitek Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 61 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 Surgitek Medical Engineering Corp. devices

FDA 510(k) Submission Details - K914505

510(k) Number K914505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1991
Decision Date December 09, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 131d · This submission: 61d
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 44
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K914505.
DISLODGER, STONE, BASKET, URETERAL, METAL
K924027 · Annex Medical, Inc. · Oct 1992
LOOP RETRIEVER
K922678 · Annex Medical, Inc. · Aug 1992
BARD 4-WIRE URETEROSCOPIC STONE
K921233 · C.R. Bard, Inc. · Apr 1992
LOOP RETRIEVER
K910603 · Annex Medical, Inc. · Mar 1991
PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
K900269 · Porges Corp. · Jul 1990
METAL URETERAL BASKET STONE DISLODGER
K896992 · Annex Medical, Inc. · Feb 1990