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510(k) K031551

NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) by Vyteris, Inc. — Product Code KTB

K031551 is an FDA 510(k) premarket notification submitted by Vyteris, Inc. for the device "NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)". The FDA issued a decision of Substantially Equivalent on August 20, 2003. The device falls under product code KTB (Device, Iontophoresis, Specific Uses), a Class II device regulated under 21 CFR 890.5525.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2003
Date Received
May 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Specific Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

Other clearances for product code KTB

  • K180627 — Macroduct Advanced Model 3710 (July 27, 2018)
  • K033192 — RH-950 (December 22, 2003)
  • K031115 — RH-900 (July 10, 2003)
  • K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (March 20, 2001)
  • K001522 — TRANSQ3 (October 18, 2000)
  • K001410 — PHORESOR MODEL PM2000 (August 1, 2000)
  • K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (November 18, 1999)
  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
  • K954126 — TRANSQ ELECTRODE PHORESOR II (January 19, 1996)
  • K895775 — CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM (April 23, 1990)

FDA data resources