Cleared Traditional

K933260 - HELICAL STONE/FLATWIRE STONE BASKETS

K933260 is an FDA 510(k) clearance for HELICAL STONE/FLATWIRE STONE BASKETS, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K933260 · Surgitek · Gastroenterology & Urology device
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Jan 1994
Decision
189d
Days
Class 2
Risk

K933260 is an FDA 510(k) clearance for the HELICAL STONE/FLATWIRE STONE BASKETS. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgitek devices

FDA 510(k) Submission Details - K933260

510(k) Number K933260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date January 11, 1994
Days to Decision 189 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 131d · This submission: 189d
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 39
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K933260.
STONE EXTRACTOR, GRASPING FORCEPS
K935737 · Boston Scientific Corp · Sep 1994
STONE EXTRACTOR
K935721 · Boston Scientific Corp · Aug 1994
ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR
K934636 · Annex Medical, Inc. · Feb 1994
METAL URETERAL BASKET STONE DISLODGER
K934675 · Annex Medical, Inc. · Jan 1994
DISLODGER, STONE, BASKET, URETERAL, METAL
K924027 · Annex Medical, Inc. · Oct 1992
LOOP RETRIEVER
K922678 · Annex Medical, Inc. · Aug 1992