Cleared Special

K143705 - NeedleCam HD Visualization System

K143705 is an FDA 510(k) clearance for NeedleCam HD Visualization System, manufactured by Biovision Technologies, LLC. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 53-day FDA review.

K143705 · Biovision Technologies, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
53d
Days
Class 2
Risk

K143705 is an FDA 510(k) clearance for the NeedleCam HD Visualization System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Biovision Technologies, LLC (Golden, US). The FDA issued a Cleared decision on February 20, 2015 after a review of 53 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. 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 Biovision Technologies, LLC devices

FDA 510(k) Submission Details - K143705

510(k) Number K143705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date February 20, 2015
Days to Decision 53 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

HRX Device Classification - Class 2, Special Controls

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 455
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K143705.
AVAflex Vertebral Balloon System
K151125 · Care Fusion · Nov 2015
AVAmax Vertebral Balloon
K150523 · Care Fusion · Oct 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · Medtronic, Inc. · Jul 2015
MITEK ARTHROSCOPES
K133941 · Medos International SARL · Apr 2014
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
K131820 · Care Fusion · Oct 2013
AVAFLEX VERTEBRAL BALLOON SYSTEM
K131824 · Care Fusion · Oct 2013