FDA 510(k)

Hysteroscope System

K-Nummer: K181545 · 2019-05-10

AntragstellerShanghai AnQing Medical Instrument Co., Ltd.

Entscheidungsdatum2019-05-10

ProduktcodeHIH

BeratungsausschussOB

EntscheidungSubstantially Equivalent

Produktübersicht

Hysteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2019-05-10 under 510(k) number K181545. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Hysteroscope System?

Hysteroscope System is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K181545.

When did Hysteroscope System receive FDA 510(k) clearance?

Hysteroscope System received FDA 510(k) clearance on 2019-05-10, under 510(k) number K181545.

Who is the listed applicant for Hysteroscope System?

The FDA 510(k) record lists Shanghai AnQing Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hysteroscope System?

The FDA product code for Hysteroscope System is HIH.

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Weitere Einträge mit Shanghai AnQing Medical Instrument Co., Ltd. als Antragsteller

K254251InnovexView (GC146-17, GC150-20, GC155-23)K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

Alle 14 Geräte anzeigen →

Verwandte Geräte (Code: HIH)

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KG K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.

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