Van-Tec Segura Stone Basket W/Protective Sheath

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K870696 ↗

FDA Product Code

FFL

Device Class

Class II

Regulation

21 CFR Part 876.4680

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Al Askari Percutaneous Access Needle Holder

  Class I

  FDA 510(k) K851162 Active Cleared 15 Apr 1985

• Van-Tec Pediatric Suprapubic Catheter Set

  Class II

  FDA 510(k) K870555 Active Cleared 10 Mar 1987

• Ureteral Catheter Connecting Tube

  Class II

  FDA 510(k) K820866 Active Cleared 26 Apr 1982

• Van-Tec Disposable Flexible Endoscope

  Class II

  FDA 510(k) K860771 Active Cleared 23 Apr 1986

• Van-Tec Bladder Evacuator

  Class II

  FDA 510(k) K880099 Active Cleared 2 Mar 1988

• Van-Tec Endopyelotomy Knife

  Class I

  FDA 510(k) K880094 Active Cleared 29 Feb 1988

See all devices from Van-Tec, Inc. →

• What is the primary use of the Van-Tec Segura Stone Basket with Protective Sheath in clinical settings?

  The Van-Tec Segura Stone Basket with Protective Sheath is designed specifically for the retrieval of urinary stones during endoscopic procedures. It is used to safely capture and remove calculi (stones) within the ureter or renal collecting system, making it a specialized tool for urological and gastroenterological applications.

• Is the device intended for single-use or can it be reused after cleaning?

  The Van-Tec Segura Stone Basket with Protective Sheath is explicitly intended for single-use only. This design ensures patient safety and sterility, as reuse could compromise the integrity of the device and introduce infection risks.

• How should the device be stored to maintain its sterility and functionality?

  The device is supplied sterile and requires no special storage conditions beyond those that preserve sterility. Standard storage practices—such as keeping it in a clean, dry environment away from direct sunlight or extreme temperatures—are sufficient to maintain its condition until use.

• What materials is the Van-Tec Segura Stone Basket with Protective Sheath made from, and how does this affect its use?

  The device is constructed from metal, which provides durability and structural integrity for capturing stones during endoscopic procedures. The metal construction ensures it can withstand the mechanical forces required for stone retrieval while remaining compatible with standard endoscopic equipment.

• What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

  The Van-Tec Segura Stone Basket with Protective Sheath received FDA 510(k) clearance (K870696) under the Traditional review pathway in 1987. It was determined to be substantially equivalent to predicate devices, allowing it to enter the market as a Class II medical device (regulated under FDA code 876.4680).