Who is the manufacturer of STONE DISLODGER, BASKET?

Boston Scientific Corp filed the 510(k) submission for STONE DISLODGER, BASKET (K970121).

What is the FDA product code for STONE DISLODGER, BASKET?

FGO. It is classified under 21 CFR 876.4680 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for STONE DISLODGER, BASKET?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like STONE DISLODGER, BASKET?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STONE DISLODGER, BASKET

Q: What are the predicate devices for STONE DISLODGER, BASKET?

K871777; K871779; K925495; K951309.

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

Related Devices

K012581 — REPROCESSED STONE RETRIEVAL BASKETS · Sterilmed, Inc. · Feb 14, 2002
K040447 — TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 · Boston Scientific Corp · Mar 12, 2004
K170811 — Single Use Retrieval Nitinol Basket V · Olympus Medical Systems Corp. · Nov 27, 2017
K974300 — TELEMED SYSTEMS RETRIEVAL BASKET · Telemed Systems, Inc. · Dec 19, 1997
K961248 — BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS · C.R. Bard, Inc. · May 28, 1996

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.