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FDA 510(k)

LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002

K-Number: K082194 · 2008-08-28

ApplicantLaurimed, LLC
Decision Date2008-08-28
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 is the device name listed in this FDA 510(k) record. The listed applicant is Laurimed, LLC. It received FDA 510(k) clearance on 2008-08-28 under 510(k) number K082194. 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 LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002?

LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is Laurimed, LLC. The 510(k) number is K082194.

When did LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 receive FDA 510(k) clearance?

LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 received FDA 510(k) clearance on 2008-08-28, under 510(k) number K082194.

Who is the listed applicant for LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002?

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 PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002?

The FDA product code for LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 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 SYSTEMK090815PERCUTANEOUS DISCECTOMY SYSTEMK083909SPINAL INJECTION SYSTEM

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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.

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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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