Cleared Traditional

K884738 - CANDELA STONE BASKETS

K884738 is the FDA 510(k) clearance for CANDELA STONE BASKETS by Candela Laser Corp.. It is a Class 2 Gastroenterology & Urology device (product code FFL) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K884738 · Candela Laser Corp. · Gastroenterology & Urology device
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Feb 1989
Decision
87d
Days
Class 2
Risk

K884738 is an FDA 510(k) clearance for the CANDELA STONE BASKETS. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on February 9, 1989 after a review of 87 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 Candela Laser Corp. devices

Submission Details

510(k) Number K884738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date February 09, 1989
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 K884738.
STONE EXTRACTOR, GRASPING FORCEPS
K935737 · Boston Scientific Corp · Sep 1994
STONE EXTRACTOR
K935721 · Boston Scientific Corp · Aug 1994
BARD 4-WIRE URETEROSCOPIC STONE
K921233 · C.R. Bard, Inc. · Apr 1992
VAN-TEC REUSABLE HELICAL STONE BASKET
K871777 · Van-Tec, Inc. · Jun 1987
HELICAL STONE BASKET (DISPOSABLE)
K871779 · Van-Tec, Inc. · Jun 1987
VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH
K870696 · Van-Tec, Inc. · Mar 1987