Cleared Special

K182882 - CrystalView Pro Irrigation Console

K182882 is the FDA 510(k) clearance for CrystalView Pro Irrigation Console by Conmed Corporation. It is a Class 2 General & Plastic Surgery device (product code HRX) cleared through the Special 510(k) pathway after a 30-day FDA review.

K182882 · Conmed Corporation · General & Plastic Surgery device
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Nov 2018
Decision
30d
Days
Class 2
Risk

K182882 is an FDA 510(k) clearance for the CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on November 14, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 888.1100 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Conmed Corporation devices

Submission Details

510(k) Number K182882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2018
Decision Date November 14, 2018
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 356
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K182882.
Pristine Scope
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K181752 · Stryker Corporation · Dec 2018
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