FDA 510(k)

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula

K-Nummer: K170660 · 2017-07-13

Entscheidungsdatum2017-07-13

ProduktcodeHIH

BeratungsausschussOB

EntscheidungSubstantially Equivalent

Produktübersicht

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2017-07-13 under 510(k) number K170660. 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 Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula?

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula is a medical device that received FDA 510(k) clearance on 2017-07-13. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K170660.

When did Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula receive FDA 510(k) clearance?

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula received FDA 510(k) clearance on 2017-07-13, under 510(k) number K170660.

Who is the listed applicant for Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula?

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

What is the FDA product code for Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula?

The FDA product code for Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula is HIH.

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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.

Offizielle Quelle

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