Endopath Surgical Instruments

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

510(k) Number

K910831 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Hot Biopsy Forceps

  Class II

  FDA 510(k) K910964 Active Cleared 2 May 1991

• Symbiosis Suction-Irrigator

  Class II

  FDA 510(k) K923563 Active Cleared 25 Nov 1992

• Symbiosis Reusable Monopolar Electrosurgical Probe

  Class II

  FDA 510(k) K941426 Active Cleared 22 Jun 1994

• Symbiosis Disposable Urological Biopsy Forceps

  Class I

  FDA 510(k) K931957 Active Cleared 28 Feb 1994

• Turkel Thoracentesis System

  Class I

  FDA 510(k) K922614 Active Cleared 30 Jul 1992

• Symbiosis Gastrointestinal Biopsy Forceps

  Class I

  FDA 510(k) K946238 Active Cleared 20 Jan 1995

See all devices from Symbiosis Corp. →

• Are the Endopath Surgical Instruments designed for single-use or can they be reused in multiple procedures?

  The Endopath Surgical Instruments are supplied as a reusable system, meaning they are intended for repeated use in controlled surgical environments. To maintain safety and performance, they must follow the manufacturer’s sterility and maintenance protocols after each use.

• What types of surgical procedures are these instruments primarily used for?

  These instruments are designed for tissue dissection, coagulation, and fluid evacuation during surgical procedures, particularly supporting minimally invasive and laparoscopic techniques. They are classified under the General and Plastic Surgery advisory committee and are suitable for those applications.

• How are the Endopath Surgical Instruments regulated in the U.S.?

  The Endopath Surgical Instruments hold an FDA 510(k) clearance (K910831) under the product code GEI, with a historical submission date of February 27, 1991. This clearance indicates they are deemed substantially equivalent to a legally marketed device, allowing their use in controlled surgical environments.

• What kind of electrosurgery principles do these instruments utilize?

  The Endopath Surgical Instruments use electrosurgery principles to provide precise control over tissue manipulation, enabling dissection, coagulation, and fluid evacuation during surgery. This technology supports minimally invasive and laparoscopic procedures in general and plastic surgery.