NeedleCam HD Visualization System

510(k) Number

K143705 ↗

FDA product code

HRX

Device class

Class II

Regulation

21 CFR Part 888.1100

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code HRX (Arthroscope).

• PANOVIEW 8871413 by Richard Wolf GmbH
• SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET by Smith & Nephew Dyonics, Inc.
• SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM by Spine-Tech, Inc.
• MEDINAUT Kyphoplasty System MKB15 by IMEDICOM CO., LTD.
• AQUACENTER 2000 SYSTEM by Aquarius Medical Corp.
• OMNI ARTHROSCOPE by Expanded Optics, Inc.
• Olympus WA4KA430 by Olympus Winter & Ibe GmbH
• SKY BONE EXPANDER SYSTEM (SKY SYSTEM) by Disc-O-Tech Medical Technologies, Ltd.
• ARTHREX ATRAUMATIC MINI-GRASPER by Arthrex, Inc.
• DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE by Stryker Instruments

• 1.2mm InnerVue II Scope Kit 922180

  Class II

  FDA 510(k) K082293 Active Cleared 9 Sep 2008 GUDID on market

• NeedleCam HD System BVT01197-00001

  Class II

  FDA 510(k) K143705 Active Cleared 20 Feb 2015 GUDID on market

• OnPoint Disposable Scope Kit 24-3000

  Class II

  FDA 510(k) K082293 Active Cleared 9 Sep 2008 GUDID on market

• InnerVue II 100mm Scope Kit 922142

  Class II

  FDA 510(k) K082293 Active Cleared 9 Sep 2008 GUDID on market

See all devices from Biovision Technologies, LLC →