510(k) K082194

LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 by Laurimed, LLC — Product Code HRX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 28, 2008
Date Received: August 4, 2008
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Arthroscope
Device Class: Class II
Regulation Number: 888.1100
Review Panel: OR
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Laurimed, LLC

K163247 — 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (March 9, 2017)
K161101 — PolypVac Microdebrider (3.3mm and 4.0mm) (June 22, 2016)
K133133 — LAURIMED POLYPVAC MICRODEBRIDER (December 23, 2013)
K091818 — LAURIMED SPINAL INJECTION SYSTEM (September 23, 2009)
K090815 — PERCUTANEOUS DISCECTOMY SYSTEM (May 21, 2009)
K083909 — SPINAL INJECTION SYSTEM (March 18, 2009)
K080140 — LAURIMED SPINAL INJECTION SYSTEM (May 9, 2008)

Other clearances for product code HRX

K252546 — VantageTM Lumbar Decompression Kit (March 12, 2026)
K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet ( (December 23, 2025)
K250795 — PUREVUE FMS (December 5, 2025)
K252666 — Articulator Arthroscopic Bur (November 21, 2025)
K252458 — Kyphoplasty Balloon Dilatation Catheters (November 3, 2025)
K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
K252594 — UltraGuideCTR® image guided soft tissue release system (September 29, 2025)
K243774 — ELID (Endoscopic Less Invasive Decompression) System (August 27, 2025)
K241990 — SpineSite Endoscope System (July 30, 2025)
K243602 — Arthrex Spine Endoscope (May 16, 2025)