Modified Uses of the Arthroscopic Surgical System

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

510(k) Number

K900070 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modified Cannula, Trocar and Obturator Accessories

  Class II

  FDA 510(k) K890665 Active Cleared 3 Nov 1989

• PS3500 Arthroscopic Surgical System

  Class II

  FDA 510(k) K892062 Active Cleared 23 Jun 1989

• Modified Saw Blades to the Sagital Saw

  Class I

  FDA 510(k) K884839 Active Cleared 7 Dec 1988

• Arthroscopic Shoulder Holder

  Class I

  FDA 510(k) K870212 Active Cleared 20 Feb 1987

• Guide to the Knee

  Class I

  FDA 510(k) K843121 Active Cleared 7 Sep 1984

• Dyonics Shoulder Portal System

  Class II

  FDA 510(k) K896416 Active Cleared 2 Jan 1990

See all devices from Dyonics, Inc. →

• What is the Modified Uses of the Arthroscopic Surgical System used for?

  It is designed for use in orthopedic procedures as an arthroscope, enabling visualization and surgical intervention within joints during minimally invasive surgery, based on its 510(k) clearance for substantially equivalent function to a predicate device.

• How was the Modified Uses of the Arthroscopic Surgical System regulated and cleared?

  It received FDA 510(k) clearance under K900070 on February 16, 1990, following a traditional review process, with clearance based on a determination of substantial equivalence to a legally marketed predicate device, and is classified as Class II under product code HRX with special controls.

• Who manufactures the Modified Uses of the Arthroscopic Surgical System and where are they located?

  The device was submitted by Dyonics, Inc., located at 160 Dascomb Rd., Andover, Massachusetts 01810, United States, with Eric Bannon listed as the contact for the submission.