Endosopic Stene Manipulating Balloon

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K850489 ↗

FDA Product Code

LQR

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Mill-Rose Harrell Bronchial Brush

  Class II

  FDA 510(k) K944649 Active Cleared 30 Nov 1994

• Stone and Retrieval Basket

  Class II

  FDA 510(k) K792344 Active Cleared 20 Dec 1979

• Esophageal Dilator Set

  Class II

  FDA 510(k) K842679 Active Cleared 2 Oct 1984

• Diathermic Snare (Cresent Type)

  Class II

  FDA 510(k) K792343 Active Cleared 18 Dec 1979

• Thoracentisis Kit

  Class I

  FDA 510(k) K894326 Active Cleared 24 Jul 1989

• Endoscopic Injection Needle

  Class II

  FDA 510(k) K820973 Active Cleared 16 Apr 1982

See all devices from Mill-Rose Laboratory →

• What is the Endoscopic Stene Manipulating Balloon used for?

  The Endoscopic Stene Manipulating Balloon is designed to manipulate and dislodge stones within the biliary tract during endoscopic procedures in gastroenterology and urology.

• Is the Endoscopic Stene Manipulating Balloon single-use or reusable?

  The device is supplied as either a single-use or reusable product depending on the specific model, though the data does not specify which models fall into each category.

• What is the regulatory status of the Endoscopic Stene Manipulating Balloon?

  The device is authorized under FDA 510(k) clearance with product code LQR and regulation number 876.5010, having been determined substantially equivalent in 1985.

• Can the Endoscopic Stene Manipulating Balloon be used in MRI procedures?

  No, the device is not indicated for MRI use according to the provided specifications.