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FDA 510(k)

PLASMAJET SYSTEM

K-Number: K030819 · 2004-08-05

ApplicantPlasma Surgical, Ltd.
Decision Date2004-08-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLASMAJET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Plasma Surgical, Ltd.. It received FDA 510(k) clearance on 2004-08-05 under 510(k) number K030819. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMAJET SYSTEM?

PLASMAJET SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-05. The listed applicant is Plasma Surgical, Ltd.. The 510(k) number is K030819.

When did PLASMAJET SYSTEM receive FDA 510(k) clearance?

PLASMAJET SYSTEM received FDA 510(k) clearance on 2004-08-05, under 510(k) number K030819.

Who is the listed applicant for PLASMAJET SYSTEM?

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

What is the FDA product code for PLASMAJET SYSTEM?

The FDA product code for PLASMAJET SYSTEM is GEI.

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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Other records listing Plasma Surgical, Ltd. as applicant

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.

K080197PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM

Related Devices (Code: GEI)

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

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

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