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FDA 510(k)

ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM

K-Number: K950255 · 1995-08-24

ApplicantArgus Medical Co., Inc.
Decision Date1995-08-24
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Argus Medical Co., Inc.. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K950255. 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 ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM?

ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Argus Medical Co., Inc.. The 510(k) number is K950255.

When did ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM receive FDA 510(k) clearance?

ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM received FDA 510(k) clearance on 1995-08-24, under 510(k) number K950255.

Who is the listed applicant for ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM?

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

What is the FDA product code for ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM?

The FDA product code for ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM is HIH.

Related Clinical Trials

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.

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Other records listing Argus Medical Co., 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.

K951624ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEMK950242ARGUS ARTHROSCOPY INSTRUMENT SYSTEMK950297ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEMK946011ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEMK950378ARGUS LAPAROSCOPY INSTRUMENT SYSTEM

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

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

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