Cleared Traditional

Endiscope, Endiscope Cervical (K180766) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180766 · Elliquence, LLC · Orthopedic device
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Jun 2018
Decision
80d
Days
Class 2
Risk

K180766 is an FDA 510(k) clearance for the Endiscope, Endiscope Cervical. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Elliquence, LLC (Baldwin, US). The FDA issued a Cleared decision on June 11, 2018 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elliquence, LLC devices

Submission Details

510(k) Number K180766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2018
Decision Date June 11, 2018
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 200
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K180766.
SMARTRELEASE Endoscopic Soft Tissue Release System
K181819 · Microaire Surgical Instruments, LLC · Nov 2018
Voyant System
K181885 · Viseon, Inc. · Oct 2018
MIDAScope and Introducer Kit, and MIDASystem
K181982 · Intravu, Inc. · Aug 2018
Single Use Arthroscopic Electrode (with Pencil)
K170703 · Modern Medical Equipment Manufacturing Limited · May 2018
DTRAX Spinal System
K180876 · Providence Medical Technology, Inc. · May 2018
ARTHRO-Pump PA304
K173311 · W.O.M. World of Medicine GmbH · May 2018