PSB Preperitoneal Structure Balloon

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

510(k) Number

K942636 ↗

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

• 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

• Laparoscopic Retractor

  Class II

  FDA 510(k) K933075 Active Cleared 3 Feb 1994

See all devices from Origin Medsystems, Inc. →

• What is the PSB Preperitoneal Structure Balloon used for?

  The PSB Preperitoneal Structure Balloon is designed to create and maintain a preperitoneal space during surgical procedures, facilitating access and visualization in the preperitoneal anatomical area for gastroenterology and urology applications.

• Is the PSB Preperitoneal Structure Balloon reusable or single-use?

  The PSB Preperitoneal Structure Balloon is supplied as a single-use product and should not be reused according to the manufacturer's instructions to ensure patient safety and device performance.

• What sizes are available for the PSB Preperitoneal Structure Balloon?

  The PSB Preperitoneal Structure Balloon is available in various sizes as specified by the manufacturer, allowing clinicians to select the appropriate size for different anatomical requirements during procedures.

• How should the PSB Preperitoneal Structure Balloon be stored?

  The PSB Preperitoneal Structure Balloon should be stored according to the manufacturer's instructions to maintain its integrity and functionality until use.