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FDA 510(k)

PolypVac Microdebrider (3.3mm and 4.0mm)

K-Number: K161101 · 2016-06-22

ApplicantLaurimed, LLC
Decision Date2016-06-22
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PolypVac Microdebrider (3.3mm and 4.0mm) is the device name listed in this FDA 510(k) record. The listed applicant is Laurimed, LLC. It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K161101. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PolypVac Microdebrider (3.3mm and 4.0mm)?

PolypVac Microdebrider (3.3mm and 4.0mm) is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Laurimed, LLC. The 510(k) number is K161101.

When did PolypVac Microdebrider (3.3mm and 4.0mm) receive FDA 510(k) clearance?

PolypVac Microdebrider (3.3mm and 4.0mm) received FDA 510(k) clearance on 2016-06-22, under 510(k) number K161101.

Who is the listed applicant for PolypVac Microdebrider (3.3mm and 4.0mm)?

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

What is the FDA product code for PolypVac Microdebrider (3.3mm and 4.0mm)?

The FDA product code for PolypVac Microdebrider (3.3mm and 4.0mm) is ERL.

Other records listing Laurimed, LLC 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.

K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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