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FDA 510(k)

NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)

K-Number: K031551 · 2003-08-20

ApplicantVyteris, Inc.
Decision Date2003-08-20
Product CodeKTB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) is the device name listed in this FDA 510(k) record. The listed applicant is Vyteris, Inc.. It received FDA 510(k) clearance on 2003-08-20 under 510(k) number K031551. The device is classified under product code KTB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)?

NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) is a medical device that received FDA 510(k) clearance on 2003-08-20. The listed applicant is Vyteris, Inc.. The 510(k) number is K031551.

When did NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) receive FDA 510(k) clearance?

NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) received FDA 510(k) clearance on 2003-08-20, under 510(k) number K031551.

Who is the listed applicant for NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)?

The FDA 510(k) record lists Vyteris, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)?

The FDA product code for NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) is KTB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KTB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180627Macroduct Advanced Model 3710Elitechgroup, Inc.K033192RH-950Iomed, Inc.K031115RH-900Iomed, Inc.K010031NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMWescor, Inc.K001522TRANSQ3Iomed, Inc.K001410PHORESOR MODEL PM2000Iomed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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