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FDA 510(k)

TULA IONTOPHORESIS SYSTEM

K-Number: K110636 · 2011-06-16

ApplicantAcclarent, Inc.
Decision Date2011-06-16
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TULA IONTOPHORESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2011-06-16 under 510(k) number K110636. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TULA IONTOPHORESIS SYSTEM?

TULA IONTOPHORESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-16. The listed applicant is Acclarent, Inc.. The 510(k) number is K110636.

When did TULA IONTOPHORESIS SYSTEM receive FDA 510(k) clearance?

TULA IONTOPHORESIS SYSTEM received FDA 510(k) clearance on 2011-06-16, under 510(k) number K110636.

Who is the listed applicant for TULA IONTOPHORESIS SYSTEM?

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

What is the FDA product code for TULA IONTOPHORESIS SYSTEM?

The FDA product code for TULA IONTOPHORESIS SYSTEM is EGJ.

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Other records listing Acclarent, Inc. as applicant

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Related Devices (Code: EGJ)

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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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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