Flexible Arthroscope

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

510(k) Number

K904465 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Graft Thrombectomy Instruments

  Class II

  FDA 510(k) K942457 Active Cleared 7 Feb 1995

• Flexible Choledochoscope

  Class II

  FDA 510(k) K901010 Active Cleared 22 May 1990

• Optical Valvulotome

  Class II

  FDA 510(k) K914385 Active Cleared 2 Mar 1992

• Angioscope

  Class II

  FDA 510(k) K934696 Active Cleared 18 Jan 1994

• Laparoscope

  Class II

  FDA 510(k) K903528 Active Cleared 4 Sep 1990

• Arthroscope

  Class I

  FDA 510(k) K931792 Active Cleared 13 Jun 1994

See all devices from Intramed Laboratories, Inc. →

• What is the Flexible Arthroscope used for?

  The Flexible Arthroscope is an electrically powered endoscope intended to visualize the interior of a joint. It is designed to assist in surgical procedures by providing clear imaging of joint structures.

• Is the Flexible Arthroscope sterile?

  No, the device is not sterilized. It requires proper handling and storage according to the manufacturer's guidelines.

• Is the Flexible Arthroscope intended for single use?

  Yes, the device is supplied as a single-use instrument and is intended for use in orthopedic procedures.

• What is the regulatory status of the Flexible Arthroscope?

  The device is regulated under FDA 510(k) clearance. The submission was reviewed by the Orthopedic review advisory committee.