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FDA 510(k)

PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM

K-Number: K080197 · 2008-06-24

ApplicantPlasma Surgical, Ltd.
Decision Date2008-06-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLASMAJET NEUTRAL PLASMA SURGERY 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 2008-06-24 under 510(k) number K080197. 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 NEUTRAL PLASMA SURGERY SYSTEM?

PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-24. The listed applicant is Plasma Surgical, Ltd.. The 510(k) number is K080197.

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

PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM received FDA 510(k) clearance on 2008-06-24, under 510(k) number K080197.

Who is the listed applicant for PLASMAJET NEUTRAL PLASMA SURGERY 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 NEUTRAL PLASMA SURGERY SYSTEM?

The FDA product code for PLASMAJET NEUTRAL PLASMA SURGERY 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.

K030819PLASMAJET 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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