Eclipse 2100 Model 32

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

Full name

Eclipse 2100(Tm) Model 32

510(k) Number

K924214 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Powersculptor Probes

  Class II

  FDA 510(k) K952755 Active Cleared 14 Sep 1995

• Eclipse Lazerblade(Tm) Fiberoptic Delivery System

  Class II

  FDA 510(k) K934935 Active Cleared 22 Nov 1993

• Eclipse 3200

  Class II

  FDA 510(k) K945126 Active Cleared 18 Jan 1995

• Sunrise Technologies Model 5020 Pldd Kit

  Class II

  FDA 510(k) K944758 Active Cleared 27 Dec 1994

• Crossfire(Tm) (705-10650)

  Class II

  FDA 510(k) K943171 Active Cleared 20 Sep 1994

• Eclipse 2100

  Class II

  FDA 510(k) K955006 Active Cleared 17 Jan 1996

See all devices from Cardiogenes →

• What is the Eclipse 2100 Model 32 used for?

  The Eclipse 2100 Model 32 is designed for surgical procedures requiring precise tissue manipulation, particularly in soft tissue or reconstructive applications. Its classification under product code GEX in general and plastic surgery indicates it aids in controlled handling of biological materials to enhance surgical outcomes.

• Is the Eclipse 2100 Model 32 reusable or single-use?

  This device is explicitly supplied as a reusable medical instrument. It is intended for use in sterile surgical environments, meaning it must be properly cleaned, sterilized, and maintained between procedures to ensure safety and compliance with medical standards.

• What regulatory pathway was used for the Eclipse 2100 Model 32?

  The Eclipse 2100 Model 32 received FDA clearance through the Traditional 510(k) pathway, with a clearance number of K924214. This pathway demonstrates that the device was determined to be substantially equivalent to a legally marketed predicate device, meeting the regulatory requirements for Class 2 surgical instruments.

• Does the Eclipse 2100 Model 32 have any special safety considerations, such as MRI compatibility?

  The available data does not specify any special MRI safety considerations for the Eclipse 2100 Model 32. Clinicians should verify compatibility with their specific MRI systems and protocols before use, as MRI safety can vary depending on the device’s materials and construction.

• How should the Eclipse 2100 Model 32 be stored?

  Since this is a reusable instrument, it should be stored in a clean, dry environment after sterilization to prevent contamination. Follow manufacturer guidelines for packaging and storage to maintain sterility and functionality until the next use. Proper storage also includes protecting the device from physical damage or exposure to chemicals.