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510(k) K994097

MEDAMICUS EPIDURAL INTRODUCER by Medamicus, Inc. — Product Code GZB

K994097 is an FDA 510(k) premarket notification submitted by Medamicus, Inc. for the device "MEDAMICUS EPIDURAL INTRODUCER". The FDA issued a decision of Substantially Equivalent on March 1, 2000. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Medamicus, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2000
Date Received
December 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5880
Review Panel
NE
Submission Type

Other clearances by Medamicus, Inc.

  • K040150 — MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (February 18, 2004)
  • K030905 — MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (April 9, 2003)
  • K022689 — MODIFICATION TO MEDAMICUS AXIA RSN (August 23, 2002)
  • K021004 — VALVED PEELABLE INTRODUCER (June 6, 2002)
  • K020563 — MEDAMICUS AXIA RSN (May 21, 2002)
  • K013120 — PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 (January 24, 2002)
  • K011085 — GUIDEWIRE INTRODUCER SAFETY NEEDLE (July 9, 2001)
  • K000824 — PERCUTANEOUS INTRODUCER, MODEL 10383-XXX (April 13, 2000)
  • K990705 — MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR S (June 28, 1999)
  • K965167 — PERCUTANEOUS VENOUS INTRODUCER 10264 (July 25, 1997)

Other clearances for product code GZB

  • K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation (August 23, 2024)
  • K221376 — Nalu Neurostimulation System (June 10, 2022)
  • K203547 — Nalu Neurostimulation System (March 25, 2021)
  • K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimula (November 9, 2020)
  • K201618 — Nalu Neurostimulation SCS system (July 15, 2020)
  • K191466 — SandShark Injectable Anchor (SIA) System (November 7, 2019)
  • K190960 — Nalu Lead Blank (50cm) (July 11, 2019)
  • K182720 — Freedom Spinal Cord Stimulator (SCS) System (March 29, 2019)
  • K183047 — Nalu Neurostimulation System (March 22, 2019)
  • K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (September 19, 2018)

FDA data resources