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FDA 510(k)

OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT

K-Number: K001203 · 2000-05-26

ApplicantThe Olympus Optical Co.
Decision Date2000-05-26
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT is the device name listed in this FDA 510(k) record. The listed applicant is The Olympus Optical Co.. It received FDA 510(k) clearance on 2000-05-26 under 510(k) number K001203. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT?

OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT is a medical device that received FDA 510(k) clearance on 2000-05-26. The listed applicant is The Olympus Optical Co.. The 510(k) number is K001203.

When did OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT receive FDA 510(k) clearance?

OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT received FDA 510(k) clearance on 2000-05-26, under 510(k) number K001203.

Who is the listed applicant for OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT?

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

What is the FDA product code for OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT?

The FDA product code for OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT is ITX.

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Other records listing The Olympus Optical Co. 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.

K032066SONOSURG SYSTEMK030194XUES-41 ENDOSCOPIC ELECTROSURGICAL UNITK021962OLYMPUS ULTRASONIC SURGICAL SYSTEMK023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESK023272DISPOSABLE ASPIRATION NEEDLE NA-200HK023767UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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