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FDA 510(k)

PERCUTANEOUS DISCECTOMY SYSTEM

K-Number: K090815 · 2009-05-21

ApplicantLaurimed, LLC
Decision Date2009-05-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS DISCECTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laurimed, LLC. It received FDA 510(k) clearance on 2009-05-21 under 510(k) number K090815. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS DISCECTOMY SYSTEM?

PERCUTANEOUS DISCECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-21. The listed applicant is Laurimed, LLC. The 510(k) number is K090815.

When did PERCUTANEOUS DISCECTOMY SYSTEM receive FDA 510(k) clearance?

PERCUTANEOUS DISCECTOMY SYSTEM received FDA 510(k) clearance on 2009-05-21, under 510(k) number K090815.

Who is the listed applicant for PERCUTANEOUS DISCECTOMY SYSTEM?

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 PERCUTANEOUS DISCECTOMY SYSTEM?

The FDA product code for PERCUTANEOUS DISCECTOMY SYSTEM is HRX.

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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)K133133LAURIMED POLYPVAC MICRODEBRIDERK091818LAURIMED SPINAL INJECTION SYSTEMK083909SPINAL INJECTION SYSTEMK082194LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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