Ideas' Port

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

510(k) Number

K913602 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• Tri-Lumen Intra Vascular Balloon Catheter (Gu Use)

  Class II

  FDA 510(k) K891588 Active Cleared 28 Sep 1989

• Tri-Lumen Intra Vascular Balloon Catheter

  Class II

  FDA 510(k) K891021 Active Cleared 18 Sep 1989

• Grice Soft Tissue Biopsy Kit

  Class II

  FDA 510(k) K922161 Active Cleared 13 Oct 1992

• Ideas Peanut Wand

  Class II

  FDA 510(k) K926335 Active Cleared 24 Jun 1993

• Grice Laparoscopic Suturing Needle

  Class II

  FDA 510(k) K921922 Active Cleared 8 Jul 1992

• Contour-Port

  Class II

  FDA 510(k) K912540 Active Cleared 23 Aug 1991

See all devices from Ideal Medical, Inc. →

• What is the IDEAS' Port used for?

  The IDEAS' Port is a Class II medical device classified as a syringe piston, designed specifically for use in general hospital settings to facilitate various medical procedures requiring precise fluid delivery.

• How is the IDEAS' Port supplied?

  The IDEAS' Port is supplied as part of a kit and is regulated under product code FMF, ensuring it meets the necessary standards for hospital applications.

• What is the regulatory status of the IDEAS' Port?

  The IDEAS' Port received FDA 510(k) clearance with number K913602 on January 2, 1992, after being received by the FDA on August 13, 1991, and is subject to regulation 880.5860.

• Is the IDEAS' Port single-use or reusable?

  The device information does not specify whether the IDEAS' Port is designed for single-use or multiple uses, so users should refer to the manufacturer's instructions for proper handling and disposal guidelines.