Duo Balloon System (Dbs) 1[10 and 12 Mm Sizes]

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

510(k) Number

K954175 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Distention Balloon

  Class II

  FDA 510(k) K953377 Active Cleared 23 Oct 1995

• Laparoscopic Balloon Retractor

  Class II

  FDA 510(k) K914203 Active Cleared 9 Oct 1991

• PSB Preperitoneal Structure Balloon

  Class II

  FDA 510(k) K942636 Active Cleared 1 Jul 1994

• Sensing Tip Surgical Trocar

  Class II

  FDA 510(k) K930848 Active Cleared 1 Mar 1994

• Port-Of-Orgin(Tm) Single-Use Trocar and Sleeve

  Class II

  FDA 510(k) K904848 Active Cleared 8 Apr 1991

• Arthroscopic Tubing Sheath

  Class II

  FDA 510(k) K896584 Active Cleared 27 Dec 1989

See all devices from Origin Medsystems, Inc. →