Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K091310 ↗

FDA Product Code

GEI

Models / Variants

Ablation Instrument, Model 1635

Ablation Multiplex Catheter, Model 1682

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Space Cpsxl Bone Cement

  Class II

  FDA 510(k) K061531 Active Cleared 30 Aug 2006

• Stabili Erx Bone Cement, Model 1135, Stabilit Vertebral Augmentation System (for Use W/ Stabilit Erx Bone Cement)

  Class II

  FDA 510(k) K090986 Active Cleared 30 Dec 2009

• Modification to Space Cpsxl Bone Cement

  Class II

  FDA 510(k) K072496 Active Cleared 5 Oct 2007

• Space 360 Delivery System

  Class II

  FDA 510(k) K070351 Active Cleared 29 Jun 2007