ENDO-GLIDE

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

510(k) Number

K013701 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Sonogel

  Class II

  FDA 510(k) K953468 Active Cleared 17 Oct 1995

• Sonoscan

  Class II

  FDA 510(k) K961692 Active Cleared 22 Aug 1996

• Ultramix

  Class II

  FDA 510(k) K962093 Active Cleared 23 Dec 1996

• Oasis

  Class II

  FDA 510(k) K964658 Active Cleared 14 Feb 1997

• Vivosonic

  Class II

  FDA 510(k) K984562 Active Cleared 8 Jun 1999

• Scantec Pad

  Class II

  FDA 510(k) K031894 Active Cleared 18 Jul 2003

See all devices from Sonotech, Inc. →

• What is the ENDO-GLIDE laparoscope used for?

  The ENDO-GLIDE is a laparoscope designed for general and plastic surgery procedures, specifically in the medical specialties of gastroenterology and urology. It provides visualization capabilities during surgical interventions.

• Is the ENDO-GLIDE single-use or reusable?

  The device data does not specify whether the ENDO-GLIDE is designed for single-use or multiple reuse. No information regarding sterility or reuse instructions is provided in the available specifications.

• What is the regulatory status of the ENDO-GLIDE?

  The ENDO-GLIDE is authorized under FDA 510(k) number K013701 with a decision of Substantially Equivalent. It is classified as a Class 2 medical device and was reviewed by the Gastroenterology and Urology advisory committee.

• Who manufactures the ENDO-GLIDE laparoscope?

  The ENDO-GLIDE is manufactured by Sonotech, Inc., located in Bellingham, Washington. The company is the applicant for the FDA 510(k) clearance and is responsible for supplying the device.