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FDA 510(k)

A4722 OLYMPUS OPTICAL OBTURATOR

K-Number: K950055 · 1995-02-21

ApplicantOlympus America, Inc.
Decision Date1995-02-21
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

A4722 OLYMPUS OPTICAL OBTURATOR is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1995-02-21 under 510(k) number K950055. 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 A4722 OLYMPUS OPTICAL OBTURATOR?

A4722 OLYMPUS OPTICAL OBTURATOR is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Olympus America, Inc.. The 510(k) number is K950055.

When did A4722 OLYMPUS OPTICAL OBTURATOR receive FDA 510(k) clearance?

A4722 OLYMPUS OPTICAL OBTURATOR received FDA 510(k) clearance on 1995-02-21, under 510(k) number K950055.

Who is the listed applicant for A4722 OLYMPUS OPTICAL OBTURATOR?

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

What is the FDA product code for A4722 OLYMPUS OPTICAL OBTURATOR?

The FDA product code for A4722 OLYMPUS OPTICAL OBTURATOR is HIH.

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Other records listing Olympus America, 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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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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