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FDA 510(k)

OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES

K-Number: K945265 · 1995-09-12

ApplicantOptus, Inc.
Decision Date1995-09-12
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Optus, Inc.. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K945265. 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 OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES?

OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Optus, Inc.. The 510(k) number is K945265.

When did OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES receive FDA 510(k) clearance?

OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES received FDA 510(k) clearance on 1995-09-12, under 510(k) number K945265.

Who is the listed applicant for OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES?

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

What is the FDA product code for OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES?

The FDA product code for OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES is HIH.

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Other records listing Optus, Inc. 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.

K945264OPTUS OTOSCOPESK953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESK945268OPTUS BRONCHOSCOPESK945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESK945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPESK945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES

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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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