Cleared Traditional

K935721 - STONE EXTRACTOR

K935721 is an FDA 510(k) clearance for STONE EXTRACTOR, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K935721 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
265d
Days
Class 2
Risk

K935721 is an FDA 510(k) clearance for the STONE EXTRACTOR. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on August 22, 1994 after a review of 265 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K935721

510(k) Number K935721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date August 22, 1994
Days to Decision 265 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
134d slower than avg
Panel avg: 131d · This submission: 265d
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 40
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K935721.
METAL URETERAL BASKET STONE DISLODGER
K951532 · Annex Medical, Inc. · Jul 1995
METEL URETERAL BASKET STONE DISLODGER
K951761 · Annex Medical, Inc. · May 1995
STONE EXTRACTOR, GRASPING FORCEPS
K935737 · Boston Scientific Corp · Sep 1994
ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR
K934636 · Annex Medical, Inc. · Feb 1994
HELICAL STONE/FLATWIRE STONE BASKETS
K933260 · Surgitek · Jan 1994
METAL URETERAL BASKET STONE DISLODGER
K934675 · Annex Medical, Inc. · Jan 1994