Instrument, Manual, General Surgical (K925707)

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

Full name

Instrument, Manual, General Surgical

510(k) Number

K925707 ↗

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. →

• What types of surgical procedures is this manual general surgical instrument designed for?

  This instrument is designed for general surgical procedures where manual precision is required, such as handling tissues, sutures, or other surgical materials. It is specifically reviewed under the General, Plastic Surgery advisory committee category, indicating its suitability for those surgical specialties. However, its use is not limited to plastic surgery—it is broadly intended for any sterile surgical environment where manual dexterity is needed.

• Is this instrument single-use or reusable, and how should it be maintained?

  This instrument is explicitly labeled as a reusable device. While the data does not specify cleaning or sterilization protocols, reusable surgical instruments typically require thorough cleaning, disinfection, and sterilization between uses to maintain sterility and prevent contamination in surgical settings. Always follow facility-specific protocols or manufacturer guidelines for proper maintenance.

• How was this device’s regulatory clearance determined, and what does ‘Substantially Equivalent’ mean in this context?

  The device received FDA 510(k) clearance under the Traditional pathway with a decision of Substantially Equivalent (SESE). This means the FDA determined that the device is as safe and effective as a legally marketed predicate device (a previously approved similar instrument) without requiring new clinical trials. The clearance was reviewed by the Surgical Devices Panel (SU) and granted on May 26, 1993, based on the manufacturer’s submission proving equivalence.

• What is the product code for this instrument, and how might it be categorized in a hospital’s inventory system?

  The product code assigned to this instrument is GEI, which is part of the FDA’s classification system for general surgical instruments. In a hospital’s inventory or procurement system, this code would likely be used to categorize it under general surgical tools or manual surgical instruments, ensuring it is grouped with similar reusable devices for stocking and maintenance purposes.