STONE DISLODGER, BASKET

K970121 · Boston Scientific Corp · FGO · Apr 2, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970121
• Device Name: STONE DISLODGER, BASKET
• Applicant: Boston Scientific Corp
• Product Code: FGO · Gastroenterology, Urology
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Stone Dislodger is intended to be used during urological and/or gastroenterological procedures including use during intracorporeal lithotripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects.

Device Story

2Fr, 8.3 mm helical stone dislodger basket; used during urological/gastroenterological procedures; facilitates endoscopic grasping, manipulation, and removal of calculi and foreign objects; utilized during intracorporeal lithotripsy; operated by physicians; mechanical device; no electronic or software components.

Clinical Evidence

Bench testing only; performance characteristics compared to predicate devices demonstrated substantial equivalence.

Technological Characteristics

2Fr diameter, 8.3 mm helical basket design; mechanical endoscopic instrument; no energy source; no software; non-powered.

Indications for Use

Indicated for patients undergoing urological or gastroenterological procedures requiring endoscopic grasping, manipulation, and removal of calculi or foreign objects.

Regulatory Classification

Identification

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• K871777
• K871779
• K925495
• K951309

Submission Summary (Full Text)

{0}

APR - 2 1997
P171
K970121

# 510 (k) Summary Of Safety And Effectiveness

**Sponsor:** Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537

**Contact Person:** Carol J. Holloway
Regulatory Affairs Specialist

**Submission Date:** January 13, 1997

**Description of Device:** 2Fr, 8.3 mm Stone Dislodger Basket, Helical Design

**Intended Uses:** The proposed Stone Dislodger is intended to be used during urological and/or gastroenterological procedures including use during intracorporeal lithotripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects.

**Substantial Equivalence:** The proposed devices are “Substantially Equivalent” to the predicate devices (K871777, K871779, K925495, K951309) indicated for use during urological and/or gastroenterological procedures to endoscopically grasp, manipulate and remove calculi and other foreign objects.

**Product Testing:** The proposed devices have been tested and compared to the predicate devices (K871777, K871779, K925495, K951309). The results indicate that the proposed devices are “Substantially Equivalent” to the predicate devices in terms of performance characteristics tested.