Cleared Traditional

K001563 - SCIPRO(TM) FLEXIBLE STONE DISLODGER AND...

K001563 is an FDA 510(k) clearance for SCIPRO(TM) FLEXIBLE STONE DISLODGER AND..., manufactured by Scion Cardiovascular, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGO cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K001563 · Scion Cardiovascular, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
187d
Days
Class 2
Risk

K001563 is an FDA 510(k) clearance for the SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET. Classified as Dislodger, Stone, Flexible (product code FGO), Class II - Special Controls.

Submitted by Scion Cardiovascular, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 2000 after a review of 187 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 Scion Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K001563

510(k) Number K001563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2000
Decision Date November 22, 2000
Days to Decision 187 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 130d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGO Device Classification - Class 2, Special Controls

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

All 9
Devices cleared under the same product code (FGO) and FDA review panel - the closest regulatory comparables to K001563.
STONE DISLODGER, BASKET
K970121 · Boston Scientific Corp · Apr 1997
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
GRASPING FORCEPS
K933261 · Surgitek · Jan 1994
INTRAVENOUS CATHETERS MODIFICATIONS
K921295 · Critikon Company, LLC · May 1993