Home / 510(k) Clearances / K023342

510(k) K023342

NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG by Hdc Corp. — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2004
Date Received
October 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

Other clearances by Hdc Corp.

  • K091390 — HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 (July 30, 2009)
  • K071875 — V-CATH POLY PICC (November 5, 2007)
  • K071851 — HDC STERILE SPIDER SCREW (October 18, 2007)
  • K052471 — HDC SPIDER SCREW (December 23, 2005)
  • K033853 — MODIFICATION TO V-CATH POLY PICC (January 14, 2004)
  • K032404 — SELDINGER SAFETY NEEDLE INTRODUCER (September 10, 2003)
  • K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-1 (September 9, 2003)
  • K022099 — SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390- (September 20, 2002)
  • K010425 — EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) (March 15, 2001)
  • K994059 — CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 (October 13, 2000)

Other clearances for product code KOI

  • K250887 — Neuromuscular Transmission Monitor TOF3D (2510091) (October 21, 2025)
  • K243339 — WiTOF (June 23, 2025)
  • K242525 — iTOF® (December 5, 2024)
  • K220530 — Tetragraph Neuromuscular Transmission Monitor (August 17, 2022)
  • K220976 — Life Scope PT BSM-1700 Series Bedside Monitor (July 21, 2022)
  • K212434 — Neuromuscular Transmission Monitor TOF3D (May 5, 2022)
  • K213316 — Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM (December 29, 2021)
  • K201949 — Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scop (May 2, 2021)
  • K192958 — TwitchView System (April 2, 2020)
  • K190795 — Tetragraph Neuromuscular Transmission Monitor (October 18, 2019)