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FDA 510(k)

GYRUS HYSTEROSCOPIC RESECTOSCOPE

K-Number: K982771 · 1999-01-21

ApplicantGyrus Medical , Ltd.
Decision Date1999-01-21
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYRUS HYSTEROSCOPIC RESECTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Medical , Ltd.. It received FDA 510(k) clearance on 1999-01-21 under 510(k) number K982771. 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 GYRUS HYSTEROSCOPIC RESECTOSCOPE?

GYRUS HYSTEROSCOPIC RESECTOSCOPE is a medical device that received FDA 510(k) clearance on 1999-01-21. The listed applicant is Gyrus Medical , Ltd.. The 510(k) number is K982771.

When did GYRUS HYSTEROSCOPIC RESECTOSCOPE receive FDA 510(k) clearance?

GYRUS HYSTEROSCOPIC RESECTOSCOPE received FDA 510(k) clearance on 1999-01-21, under 510(k) number K982771.

Who is the listed applicant for GYRUS HYSTEROSCOPIC RESECTOSCOPE?

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

What is the FDA product code for GYRUS HYSTEROSCOPIC RESECTOSCOPE?

The FDA product code for GYRUS HYSTEROSCOPIC RESECTOSCOPE is HIH.

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Other records listing Gyrus Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041285GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)K003569PLASMAKINETIC ENDOUROLOGY SYSTEMK001270GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODEK994166GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODEK993749GYRUS HYSTEROSCOPIC RESECTOSCOPEK990628GYRUS ENDOUROLOGY SYSTEM

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Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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. KGK261102UNIDRIVE Select SystemKarl Storz SE & CO. KGK254294Single-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.

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