Symbiosis Dispos Gastro Biopsy Forceps W/Reuse Han

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K932266 ↗

FDA Product Code

KGE

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

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 procedures is this biopsy forceps system designed for, and how does its reusable handle feature benefit the user?

  The Symbiosis Dispos Gastro Biopsy Forceps with Reuse Handle is specifically designed for endoscopic biopsy procedures in the gastrointestinal tract, including both upper and lower endoscopy. The reusable handle paired with single-use disposable forceps ensures sterility for each procedure, reducing contamination risks and streamlining workflow. This design also allows clinicians to maintain a consistent grip and ergonomic feel while switching between sterile forceps, improving efficiency during repeated biopsies.

• Are the disposable forceps compatible with multiple reusable handles, and how should they be stored to maintain sterility?

  The device is structured as a single-use disposable forceps component paired with a reusable handle, meaning each disposable forceps is intended for one procedure only. Storage should follow standard sterile instrument protocols for endoscopic accessories, such as keeping them in a sealed, sterile packaging until use and avoiding exposure to moisture or contamination. The reusable handle should be cleaned and sterilized between uses per manufacturer guidelines.

• What medical specialties can use this device, and does it have any size variations or model-specific features?

  This device is intended for use in gastroenterology and urology settings, as indicated by its FDA clearance and advisory committee classification. While the data lists multiple registration numbers (suggesting potential size or model variations), the core design remains consistent: disposable biopsy forceps with a reusable handle. Specific sizes or models aren’t detailed in the provided data, but the forceps are designed for precise tissue acquisition during endoscopic procedures, ensuring compatibility with standard endoscopic instruments.

• How is the sterility of the disposable forceps ensured, and can the reusable handle be reused across different patients?

  The disposable forceps are sterile for single-use only, as part of the device’s design to prevent cross-contamination between patients. The reusable handle, however, is intended for multiple uses across different patients, provided it is cleaned and sterilized between procedures according to standard medical device reprocessing protocols. This dual-use approach balances convenience with infection control.