FDA 510(k)

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

K-Nummer: K201840 · 2020-11-04

Entscheidungsdatum2020-11-04

ProduktcodeGWG

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is the device name listed in this FDA 510(k) record. The listed applicant is Rebound Therapeutics. It received FDA 510(k) clearance on 2020-11-04 under 510(k) number K201840. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is a medical device that received FDA 510(k) clearance on 2020-11-04. The listed applicant is Rebound Therapeutics. The 510(k) number is K201840.

When did Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) receive FDA 510(k) clearance?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) received FDA 510(k) clearance on 2020-11-04, under 510(k) number K201840.

Who is the listed applicant for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

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

What is the FDA product code for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

The FDA product code for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is GWG.

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Weitere Einträge mit Rebound Therapeutics als Antragsteller

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Verwandte Geräte (Code: GWG)

K253602Precision S 4K SinuscopeStryker Endoscopy K253679Hydro Irrigation SystemStryker Instruments K243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences Corporation K233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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