Spinal Needle

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K880812 ↗

FDA Product Code

GDM

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cervical Self-Retaining Retractor

  Class II

  FDA 510(k) K935529 Active Cleared 22 Mar 1994

• Sternum Spreader and Mitral Valve Retractor

  Class I

  FDA 510(k) K881157 Active Cleared 6 Apr 1988

• Percutaneous Discectomy Cannula System

  Class II

  FDA 510(k) K954014 Active Cleared 6 Nov 1995

• Sternum Spreader, Pediatric

  Class I

  FDA 510(k) K880998 Active Cleared 21 Mar 1988

• Reusable Endoscopic Scissors, Grasper-Monopolar

  Class II

  FDA 510(k) K926583 Active Cleared 6 Aug 1993

• Videoscope W/Irrigation Sheath

  Class II

  FDA 510(k) K954016 Active Cleared 25 Jan 1996

See all devices from T. Korossurgical Instruments Corp. →