Nucleotome E Kit

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

510(k) Number

K931109 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SN

• Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000

  Class II

  FDA 510(k) K950495 Active Cleared 9 May 1995

• Surgical Dynamics 30K Working Channel Scope & Instrument Set

  Class II

  FDA 510(k) K954193 Active Cleared 23 Oct 1995

• Surgical Dynamics Nucleotome II Tissue Aspir/Cuter

  Class II

  FDA 510(k) K902778 Active Cleared 30 Oct 1990

• Nucleotome L Kit

  Class I

  FDA 510(k) K942987 Active Cleared 30 Oct 1995

• Hematome System

  Class I

  FDA 510(k) K885066 Active Cleared 1 May 1989

• Nucleotome(R) II (VERSION2) Tissue Aspira/Cutter

  Class II

  FDA 510(k) K914282 Active Cleared 19 Dec 1991

See all devices from Surgical Dynamics, Inc. →

• What is the Nucleotome E Kit used for in clinical practice?

  The Nucleotome E Kit is a surgical microscope designed for use in orthopedic procedures. It is supplied as a kit and is intended to support surgical interventions within orthopedic settings, as indicated in the device description.

• How is the Nucleotome E Kit supplied to healthcare facilities?

  The device is supplied as a kit by Surgical Dynamics, Inc., based in Alameda, California. The kit format suggests it is packaged to include necessary components for its intended use in orthopedic surgery, facilitating ready deployment in clinical environments.

• Is the Nucleotome E Kit a single-use or reusable device?

  The device data does not specify whether the Nucleotome E Kit is single-use or reusable. This information would typically be found in the manufacturer's labeling or instructions for use, which are not included in the provided data.

• What sizes or models are available for the Nucleotome E Kit?

  The provided data does not list specific sizes, models, or variations of the Nucleotome E Kit. It is referenced as a single product name under manufacturer Surgical Dynamics, Inc., with no additional configuration details included in the specifications.

• How should the Nucleotome E Kit be stored prior to use?

  Storage conditions for the Nucleotome E Kit are not detailed in the available data. For proper handling, including temperature, humidity, and shelf-life requirements, consulting the manufacturer’s package insert or contact information (Charmaine Henderson, Alameda, CA) is recommended.