Cleared Traditional

K970121 - STONE DISLODGER

K970121 is the FDA 510(k) clearance for STONE DISLODGER by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGO) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K970121 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
78d
Days
Class 2
Risk

K970121 is an FDA 510(k) clearance for the STONE DISLODGER, BASKET. Classified as Dislodger, Stone, Flexible (product code FGO), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 78 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 Boston Scientific Corp devices

Submission Details

510(k) Number K970121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1997
Decision Date April 02, 1997
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGO Dislodger, Stone, Flexible
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 - FGO Dislodger, Stone, Flexible

Devices cleared under the same product code (FGO) and FDA review panel - the closest regulatory comparables to K970121.
RETRIEVAL SNARE
K963750 · Boston Scientific Corp · Nov 1996
DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
K962676 · United States Endoscopy Group, Inc. · Oct 1996
STONE DISLODGER, BASKET
K951309 · Boston Scientific Corp · May 1995
INTRAVENOUS CATHETERS MODIFICATIONS
K921295 · Critikon Company, LLC · May 1993
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH
K885168 · Boston Scientific Corp · Sep 1989
PFISTER-SCHWARTZ STONE RETRIEVER
K771302 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1977