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FDA 510(k)

ELID (Endoscopic Less Invasive Decompression) System

K-Number: K243774 · 2025-08-27

ApplicantLesspine Innovations
Decision Date2025-08-27
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELID (Endoscopic Less Invasive Decompression) System is the device name listed in this FDA 510(k) record. The listed applicant is Lesspine Innovations. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K243774. 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 ELID (Endoscopic Less Invasive Decompression) System?

ELID (Endoscopic Less Invasive Decompression) System is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Lesspine Innovations. The 510(k) number is K243774.

When did ELID (Endoscopic Less Invasive Decompression) System receive FDA 510(k) clearance?

ELID (Endoscopic Less Invasive Decompression) System received FDA 510(k) clearance on 2025-08-27, under 510(k) number K243774.

Who is the listed applicant for ELID (Endoscopic Less Invasive Decompression) System?

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

What is the FDA product code for ELID (Endoscopic Less Invasive Decompression) System?

The FDA product code for ELID (Endoscopic Less Invasive Decompression) System is HRX.

Other records listing Lesspine Innovations as applicant

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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.

K252790Digital 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)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC

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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