FDA 510(k)

Neo - Arthroskop (Rigide) 2,0 mm/3,5 mm, Außenkanüle, Außenkanüle mit Griff, Trokar für Außenkanüle

K-Nummer: K152511 · 2016-07-11

Entscheidungsdatum2016-07-11

ProduktcodeHRX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2016-07-11 under 510(k) number K152511. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula?

Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula is a medical device that received FDA 510(k) clearance on 2016-07-11. The listed applicant is Prosurg, Inc.. The 510(k) number is K152511.

When did Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula receive FDA 510(k) clearance?

Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula received FDA 510(k) clearance on 2016-07-11, under 510(k) number K152511.

Who is the listed applicant for Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula?

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

What is the FDA product code for Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula?

The FDA product code for Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula is HRX.

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Weitere Einträge mit Prosurg, Inc. als Antragsteller

K152466Neo-Bronchoskop - Digitales Videobronchoskop-System (Rigides/Flexibles)K152619Neoscope 3D - 3D-Digitales Videokamera-Endoskopensystem (Rigide/Flexibel)

Verwandte Geräte (Code: HRX)

K260203Fule Vertebroplastik BallonkatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Teleskope für ArthroskopieKarl Storz SE & CO. KG K252790Digital ClarusScope-System und Digital NeuroPEN-SystemClarus Medical, LLC K253523Freedom DS™ DekompressionsystemSpinal Simplicity K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC K253217MiiS Horus Arthroskop (EJA 100); MiiS Horus Endoskop Anzeigesystem -Tablet (EDS 500); MiiS Horus Endoskop Anzeigesystem -Video-Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

Offizielle Quelle

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