FlexStone Basket

Basic Information

• Brand Name: FlexStone Basket
• Primary DI: G380FSA120210
• Version / Model: FSA-120-21
• Company Name: EndoTheia, Inc.
• Labeler DUNS: 081343728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-16
• Public Version: 1
• Public Version Date: 2025-04-24
• Public Version Status: New
• Public Device Record Key: c8ae4fef-d7c4-4d69-8e1c-ab17a7ac8846

Device Description

Single-Use Steerable Basket

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	876.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44333	Urinary stone retrieval basket, single-use	A manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G380FSA120210	HIBCC
Package	G380FSA120211	HIBCC		1	In Commercial Distribution
Package	G380FSA120212	HIBCC	Shipper Box	4	In Commercial Distribution