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FDA 510(k)

PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL

K-Number: K103375 · 2011-03-16

ApplicantMedtek Devices, Inc.
Decision Date2011-03-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL is the device name listed in this FDA 510(k) record. The listed applicant is Medtek Devices, Inc.. It received FDA 510(k) clearance on 2011-03-16 under 510(k) number K103375. 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 PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL?

PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL is a medical device that received FDA 510(k) clearance on 2011-03-16. The listed applicant is Medtek Devices, Inc.. The 510(k) number is K103375.

When did PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL receive FDA 510(k) clearance?

PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL received FDA 510(k) clearance on 2011-03-16, under 510(k) number K103375.

Who is the listed applicant for PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL?

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

What is the FDA product code for PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL?

The FDA product code for PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL is GEI.

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Other records listing Medtek Devices, Inc. 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.

K052797LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM

Related Devices (Code: GEI)

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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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