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FDA 510(k)

LAURIMED POLYPVAC MICRODEBRIDER

K-Number: K133133 · 2013-12-23

ApplicantLaurimed, LLC
Decision Date2013-12-23
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LAURIMED POLYPVAC MICRODEBRIDER is the device name listed in this FDA 510(k) record. The listed applicant is Laurimed, LLC. It received FDA 510(k) clearance on 2013-12-23 under 510(k) number K133133. 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 LAURIMED POLYPVAC MICRODEBRIDER?

LAURIMED POLYPVAC MICRODEBRIDER is a medical device that received FDA 510(k) clearance on 2013-12-23. The listed applicant is Laurimed, LLC. The 510(k) number is K133133.

When did LAURIMED POLYPVAC MICRODEBRIDER receive FDA 510(k) clearance?

LAURIMED POLYPVAC MICRODEBRIDER received FDA 510(k) clearance on 2013-12-23, under 510(k) number K133133.

Who is the listed applicant for LAURIMED POLYPVAC MICRODEBRIDER?

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 LAURIMED POLYPVAC MICRODEBRIDER?

The FDA product code for LAURIMED POLYPVAC MICRODEBRIDER is ERL.

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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 MicrodebriderK161101PolypVac Microdebrider (3.3mm and 4.0mm)K091818LAURIMED SPINAL INJECTION SYSTEMK090815PERCUTANEOUS DISCECTOMY SYSTEMK083909SPINAL INJECTION SYSTEMK082194LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002

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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

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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