FDA 510(k)

ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC

K-Number: K092421 · 2010-02-12

Decision Date2010-02-12

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC is the device name listed in this FDA 510(k) record. The listed applicant is Gimmi GmbH. It received FDA 510(k) clearance on 2010-02-12 under 510(k) number K092421. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC?

ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is Gimmi GmbH. The 510(k) number is K092421.

When did ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC receive FDA 510(k) clearance?

ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC received FDA 510(k) clearance on 2010-02-12, under 510(k) number K092421.

Who is the listed applicant for ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC?

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

What is the FDA product code for ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC?

The FDA product code for ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC is HIH.

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Other records listing Gimmi GmbH as applicant

K261179AlphaTriPart - Monopolar MIC Instruments K093125ALPHAXENON LIGHT 180 W AND 300 W K081640GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS K012869GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 K012660GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES K013731GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03

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Related Devices (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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.