Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)
FDA 510(k) K031551 · Vyteris, Inc.
510(k) numberK031551
Submission
- Device name
- Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)
- Applicant
- Vyteris, Inc.
Fair Lawn, NJ, US - Received
- May 19, 2003
- Decision date
- August 20, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTB – Device, Iontophoresis, Specific Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
Other 510(k)s with product code KTB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180627 | Macroduct Advanced Model 3710KTB · Traditional | Elitechgroup, Inc. | 07/27/2018SE |
| K033192 | RH-950KTB · Traditional | Iomed, Inc. | 12/22/2003SE |
| K031115 | RH-900KTB · Traditional | Iomed, Inc. | 07/10/2003SE |
| K010031 | Nanoduct Neonatal Sweat Analysis SystemKTB · Special | Wescor, Inc. | 03/20/2001SE |
| K001522 | TRANSQ3KTB · Traditional | Iomed, Inc. | 10/18/2000SE |
| K001410 | Phoresor Model PM2000KTB · Traditional | Iomed, Inc. | 08/01/2000SE |
| K992874 | Q-Sweat Quantitative Sweat Measurement SystemKTB · Traditional | Wr Medical Electronics Co. | 11/18/1999SE |
| K974855 | Phoresor II, Model PM900KTB · Traditional | Iomed, Inc. | 03/27/1998SN |
| K954126 | Transq Electrode Phoresor IIKTB · Traditional | Iomed, Inc. | 01/19/1996SN |
| K895775 | CF Indicator Model 9800 Sweat Test SystemKTB · Traditional | Medtronic Vascular | 04/23/1990SE |
Questions and answers
When was Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D) cleared by the FDA?
Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D) (K031551) received a 510(k) decision of Substantially Equivalent on August 20, 2003, 93 days after the submission was received.
What is the product code of K031551?
The FDA product code is KTB – Device, Iontophoresis, Specific Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.